Controlled arterial/venous access

ABSTRACT

Apparatus and methods for controlled arterial/venous access are provided. The apparatus and methods may include a section of tubing anastomosed to a bodily lumen. A lumen clamping means may utilize a clamp manipulator to effectively seal the tubing, and the manipulator may be operated by two fingers. A needle receptor may be utilized, and the receptor may utilize a rotating member to guide a needle inserted from outside the body, in order ensure accurate placement into a channel. The channel may be in liquid communication with the tubing. The manipulator and the needle receptor may be palpable from outside the body.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation in Part of U.S. patent applicationSer. No. 15/621,292, which is in turn, a Continuation in Part of U.S.Patent Application No. US 2014/0276327 A1, now issued as U.S. Pat. No.10,105,479 B2, which is a nonprovisional of U.S. Provisional ApplicationNo. 61/788,962, filed on Mar. 15, 2013 each of which is herebyincorporated by reference in its entirety.

FIELD OF TECHNOLOGY

Aspects of the invention relate to a controlled valve for accessing ablood vessel.

BACKGROUND

Various therapeutic treatments require access to blood flowing through acirculatory system. For example, treatments in the fields of hematology,oncology and/or pharmacology may require direct access to circulatingblood. Some treatments, such as dialysis, require an extraction andreintroduction of blood. The blood extracted from the body is filtered,waste products are removed and the filtered and “clean” blood isreintroduced into the circulatory system.

To perform dialysis, it is necessary to have access to the blood, whileit is in circulation. Additionally, the access to the blood should bearranged to provide a high extraction throughput or flow rate. The flowrate allows a sufficient amount of blood to be extracted within a givenperiod of time. Efficacy of the dialysis procedure may be dependent uponthe extraction throughput. Treatment costs as well as patient comfortusually coincide with efficient procedures.

When performing dialysis, one method of accessing the blood is via anintravenous catheter. The catheter may be inserted into a large vein.Large veins, such as the vena cava, jugular vein or femoral vein, allowfor a higher extraction throughput than do other veins.

However, a catheter is a foreign body in the vein, and may triggervenous stenosis in or around the vein wall. The venous stenosis may scarand occlude the vein. As a result of the stenosis and occlusion,multiple access sites must be utilized and a patient on long termdialysis may “run out” of usable veins for catheter access. In addition,a catheter protrudes out of a patient's skin, and staving off infectionis a common challenge when employing catheter access. However, thepatient may desire catheter access because, after insertion, accessingthe patient's blood through connection of the catheter to a dialysismachine does not require repeated needle pricks.

Another access method is to surgically form an arteriovenous (“AV”)fistula. To form the fistula, a surgeon joins an artery to a vein,bypassing narrow capillaries. Arteries carry blood away from the heartand blood typically flows faster, and at a higher pressure, througharteries than veins. By transferring directly from an artery to a veinwithout intervening capillaries, blood flows swiftly at a high pressurefrom the artery into the vein. A fistula is formed by creating ananastomosis between and artery and vein. However, the fistula may take1-4 months to mature the vein prior to being accessed for dialysis.

After maturity, two needles are inserted into the vein distal to thefistula anastomosis. A first needle extracts blood which is transferredto a dialysis machine. A second needle receives the filtered blood fromthe dialysis machine and reintroduces the filtered blood into the vein.

A fistula is characterized by lower infection rates than catheteraccess. However, because the fistula is always “on” and blood is alwaysflowing through the fistula, the fistula may stimulate a “stealsyndrome.” The steal syndrome occurs when insufficient blood flowreaches the bypassed capillaries. Blood may be drawn through the fistulaand returned to general circulation through the vein, preventingadequate blood flow to extremities of a limb. The steal syndrome mayresult in coldness in the extremities and ischemic tissue damage ifsevere. Since the fistula is always “on”, some patients face issues withcardiac failure since their heart is now tasked with a constantlyincreased cardiac output. If the patient's heart is unable to perform atsuch a cardiac output, it can lead to congestive heart failure.

A fistula may also be associated with development of an aneurysm in thevein. While undergoing dialysis, needles must be regularly inserted intoveins distal to the fistula to reintroduce blood to the circulatorysystem. The needle insertions may weaken a wall of the vein, as theymust be repeated for every treatment. The repeated needle sticks may berepeated at convenient, or easily accessible, areas in the anatomy,thereby increasing the likelihood of an aneurysm.

Another dialysis access method is to create an AV graft. The graftoperates under principles similar to the fistula. The graft is anartificial conduit that transfers blood flow from an artery directlyinto a vein. Unlike the fistula, the graft joins the artery and veinusing a synthetic material. Unlike a fistula, a graft does not need tomature allowing for earlier usage, and may be used in cases where apatient's anatomy is not optimal for creation of a fistula. The graftmay be made of a length sufficient to join two blood vessels distantfrom each other.

However, grafts are made from synthetic materials, and are foreign tothe body. While a synthetic graft may be sized ideally to the anatomy,they are associated with a higher rate of thrombosis. The thrombosis mayresult from stenosis within natural arteries and veins adjacent to theanastomoses at each end of the graft. Grafts are also typicallyassociated with a higher rate of infection than the fistula.

Furthermore, like a fistula, a graft cannot be turned “off,” and evenafter completion of a dialysis procedure, blood is constantly flowingthrough the graft. Again, this situation is not ideal for the tissuewhich may be transfusing significantly less blood than normal.

It would be desirable to obtain benefits of a fistula/graft withoutthese numerous associated disadvantages. It would be desirable toprovide blood access that is associated with a high throughput and thatmay be “turned off” after a treatment. It would be desirable to provideregular access to blood without damaging a blood vessel as a result ofrepeated needle pricks. Therefore, it would be very beneficial toprovide apparatus and methods for a valve for accessing a blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and advantages of the invention will be apparent uponconsideration of the following detailed description, taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1 shows an illustrative therapeutic scenario in accordance withprinciples of the invention;

FIG. 2 shows illustrative apparatus in accordance with principles of theinvention;

FIG. 3A shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 3B shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 4 shows illustrative apparatus in accordance with principles of theinvention;

FIG. 5A shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5B shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5C shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5D shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5E shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5F shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 5G shows illustrative therapeutic scenarios and associatedapparatus in accordance with principles of the invention;

FIG. 6A shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 6B shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 7 shows illustrative apparatus in accordance with principles of theinvention;

FIG. 8 shows illustrative apparatus in accordance with principles of theinvention;

FIG. 9 shows an illustrative process in accordance with principles ofthe invention;

FIG. 10 shows an illustrative process in accordance with principles ofthe invention;

FIG. 11 shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 12 shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 13A shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 13B shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 14 shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 15A shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 15B shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 16 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 17 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 18 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 19 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 20 shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIG. 21 shows an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIGS. 22A-22C show an illustrative therapeutic scenario and associatedapparatus in accordance with principles of the invention;

FIGS. 23A-23B show an illustrative process in accordance with principlesof the invention;

FIG. 24 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 25 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 26 shows illustrative apparatus in accordance with principles ofthe invention;

FIGS. 27A-27B show illustrative apparatus in accordance with principlesof the invention;

FIG. 28 shows illustrative apparatus in accordance with principles ofthe invention;

FIG. 29 shows illustrative apparatus in accordance with principles ofthe invention;

FIGS. 30A-30B show illustrative apparatus in accordance with principlesof the invention; and

FIG. 31 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 32 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 33 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 34 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 35 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 36 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 37 shows illustrative apparatus in accordance with principles ofthe invention.

FIG. 38 shows illustrative apparatus in accordance with principles ofthe invention.

DETAILED DESCRIPTION OF THE DISCLOSURE

Apparatus and methods for a hydraulic access port are provided. Inanother embodiment, an apparatus and method for an implantablesubcutaneous access valve having palpable elements are provided.

Apparatus may include, and methods may involve, a transport system. Thetransport system may include a port. The port may be coupled to a bloodvessel. The blood vessel may be an artery. The blood vessel may be avein. The blood vessel may be any suitable blood vessel. The port may becoupled to any suitable conduit carrying a medium.

The port may include an expandable chamber. The port may include arotatable swing-arm. The port may include a sealable passageway. Theport may include an orifice. The orifice may allow blood to flow betweenthe blood vessel and the port.

The transport system may include tubing. The tubing may be coupled tothe port. The tubing may include a first lumen. The tubing may include asecond lumen. The second lumen may be in fluid connection with theexpandable chamber. The second lumen may be expandable. The second lumenmay be oriented inferiorly with respect to the first lumen. Expansion ofthe second lumen may be configured to collapse the first lumen.Expansion of the second lumen may be configured to seal the first lumen.

The transport system may include a reservoir. The reservoir may becoupled to the tubing. The reservoir may be coupled to the port. Thereservoir may include a first collapsible chamber. The first collapsiblechamber may be coupled to the sealable passageway of the port. The firstcollapsible chamber may be capped with a first membrane.

The reservoir may include a second chamber. The second chamber may be influid connection with the second lumen. The second chamber may be influid connection with the expandable chamber of the port. The secondchamber may be capped with the first membrane. The second chamber may becapped with a second membrane.

The port may include a swing-arm. An injection of a medium into thesecond chamber may be configured to articulate the swing-arm. Movementof the swing-arm may seal the sealable passageway of the port. Theinjection of the medium into the second chamber may position theswing-arm over an orifice in the port. Expansion of the expandablechamber of the port may position the swing-arm over the orifice. Theposition of the swing-arm may be maintained by a pressure in thetransport system. The pressure may be maintained, at least in part, bythe first and/or second membranes.

The transport system may be a first transport system. Apparatus mayinclude, and methods may involve, a first transport system and a secondtransport system. The first transport system may be coupled to a firstblood vessel. The second transport system may be coupled to a secondblood vessel.

Apparatus may include, and methods may involve, a tubing. The tubing mayinclude a first end coupled to a blood vessel. The tubing may include asecond end. The second end may be coupled to a subcutaneous reservoir.The tubing may include a first sealable lumen. The first sealable lumenmay be configured to transport blood. The tubing may include a secondexpandable lumen configured to seal the first lumen.

Apparatus may include, and methods may involve, a transport system. Thetransport system may include a subcutaneous central reservoir. Thesubcutaneous central reservoir may include a first chamber. The firstchamber may be in fluid connection with a lumen of a first tubing. Thefirst chamber may be in fluid connection with a first lumen of a secondtubing.

The subcutaneous central reservoir may include a second chamber. Thesecond chamber may be coupled to a second lumen of the first tubing.

The subcutaneous central reservoir may include a third chamber. Thethird chamber may be coupled to a second lumen end of the second tubing.

The transport system may include a first port. The first port may becoupled to the first lumen of the first tubing. The first port may becoupled to the second lumen of the first tubing.

The transport system may include a second port. The second port may becoupled to the first lumen of the second tubing. The second port may becoupled to the second lumen of the second tubing.

Apparatus may include, and methods may involve, a transport system. Thetransport system may include a reservoir. The reservoir may include afirst chamber. The first chamber may be collapsible and expandable. Thereservoir may include a second chamber. The second chamber may becollapsible and expandable.

The transport system may include tubing. The tubing may be coupled tothe reservoir using a barb or adapter. The tubing may include a firstlumen. The first lumen may link the first chamber to a fluid carryingconduit. The conduit may be a blood vessel. The blood vessel may beanastomized to the tubing.

The tubing may include a second lumen. The second lumen may link thesecond chamber to a balloon. The second lumen may terminate at theballoon. The second lumen may be in fluid communication with theballoon. The balloon may encircle the first lumen. The balloon mayencircle a portion of the first lumen. The balloon may encircle aportion of the tubing that does not compress or deform when the balloonis inflated.

The system may include a clamp. The clamp may be coupled to the tubing.The clamp may be rotatably coupled to the tubing. The clamp may beconfigured to rotate about a pivot affixed to the tubing.

The clamp may expand about the first lumen in response to inflation ofthe balloon. The inflation of the balloon may overcome a force biasingthe clamp in a closed position. The clamp may compress the first lumenin response to deflation of the balloon. The clamp may compress asection of the first lumen. The clamp may compress the first lumen in aclosed position.

Compressing the first lumen may seal the system from the conduit andfluid flowing through the conduit. Compressing the first lumen may allowfluid carried through the conduit to flow without being impeded by thetubing.

The reservoir may include a septum. The septum may include aself-sealing membrane. The reservoir may include a moveable platform.The moveable platform may be disposed between a first chamber and asecond chamber of the reservoir.

The reservoir may include a biasing member. The biasing member may be aspring or any suitable pressure source. The biasing member may bias themoveable platform toward the septum. In some embodiments, the biasingmember may bias the moveable platform to press against the septum.

The reservoir may include a bladder. The bladder may reside within thesecond chamber of the reservoir. The bladder may be in fluidcommunication with the balloon. The second lumen may provide fluidcommunication between the bladder and the balloon.

Pressure may be applied to the moveable platform. A needle may beinserted into the reservoir through the septum. A tip of the needle mayexert pressure on the moveable platform. The pressure may push down onthe moveable platform. The moveable platform may include a slopingsurface to direct the needle to a center of the platform. The movableplatform may be flat, convex, concave or have any suitable surface. Inresponse to the pressure, the moveable platform may compress thebladder. Compressing the bladder may inflate the balloon with fluidtransferred from the bladder to the balloon via the second lumen.

The transport system may include a locking mechanism. The lockingmechanism may engage when the moveable platform is moved apre-determined distance away from the septum. After moving thepre-determined distance, a protrusion coupled to the platform may beseated into a well of the locking mechanism. Seating the protrusion inthe well may prevent the biasing member of the reservoir from moving theplatform toward the septum.

Seating the protrusion in the well may lock the moveable platform in aposition that maintains compression of the bladder and correspondinginflation of the balloon. The locking mechanism may be disengaged whenthe moveable platform is moved the pre-determined distance from theseptum. The platform may be moved by applying pressure to the platform.Moving the platform the pre-determined distance may shift the protrusionout of the well.

The well may be a relatively deep well. Pressure applied to the platformmay press the protrusion against a guide. The guide may direct theprotrusion into a shallow well. When in the shallow well, the platformmay allow fluid expelled by compressing the bladder to reenter thebladder. Deflation of the balloon may exert pressure that pushes fluidout of the balloon into the bladder.

The second distance may be equal to the first distance. The seconddistance may be greater than the first distance. The second distance maybe less than the first distance.

Tubing may include an inflexible portion. The inflexible portion mayextend along a first segment of the first lumen. In some embodiments thefirst segment of the first lumen may correspond to a segment of thefirst lumen that passes through the second lumen.

The first lumen may include a flexible portion. The flexible portion mayextend along a second segment of the first lumen. The second segment ofthe first lumen may include a segment of the first lumen between theballoon and a junction of the first lumen and the conduit.

The flexible portion of the tubing may include a flared end. The flaredend may be configured to be anastomized to the conduit. For example,when the conduit is a blood vessel, the flared end may be sutured,stapled or hooked onto the blood vessel.

The clamp may be biased to compress the flexible portion of the tubing.Compressing the flexible portion of the tubing may prevent fluid flowingthrough the conduit from entering the first lumen. Compressing theflexible portion of the tubing may allow fluid to flow through theconduit unimpeded by the first lumen.

Inflating the balloon may overcome the biasing force applied to theclamp. Overcoming the biasing force may open the first lumen to fluidflowing through the conduit. Deflating the balloon may allow the clampto fluidly seal the first lumen from the conduit.

In some embodiments the clamp may be biased in an open position. Theballoon may be positioned around an outside of the clamp. In suchembodiments, inflating the balloon may close the clamp and deflating theballoon may allow the clamp to open.

The clamp may include a first rotatable arm. The clamp may include asecond rotatable arm. The first and second rotatable arms may beconfigured to rotate about a pivot.

The first rotatable arm may be inserted into a sleeve. The sleeve maymaintain a position of the clamp relative to a junction of the tubingand the conduit. The sleeve may prevent the clamp from shifting out ofposition when the conduit shifts. The sleeve may prevent a twisting ofthe clamp about a longitudinal axis of the first lumen.

For example, the transport system may be implanted in a human body.Locomotion of the body may shift a position of the conduit with respectto the tubing. The sleeve may ensure that the clamp is positioned toseal the flexible portion of the tubing despite shifting of the conduit.

The sleeve may be a first sleeve. In some embodiments, a secondrotatable arm of the clamp may be inserted into a second sleeve. Thefirst sleeve may maintain a position of the first rotatable arm relativeto the junction. The second sleeve may maintain a position of the secondrotatable arm relative to the junction.

The sleeves may be formed at least in part, by a portion of the tubing.The sleeves may be formed from solid non-thrombogenic plastic or anysuitable materials. Exemplary suitable materials may include Dacron,Gore-Tex, polytetrafluoroethylene (“PTFE”), fluoropolymer products andany material suitable for implantation in a human body.

Apparatus may include, and methods may involve, a graft. The graft maybe attached to a conduit. The conduit may be an artery or a vein or acarrier or any suitable medium. The graft may include tubing configuredto be anastomized to the conduit. The tubing may include a compressibleportion. The tubing may include a non-compressible portion. Thecompressible portion may be located between the conduit and thenon-compressible portion of the tubing.

The graft may include a clamp. The clamp may be rotatable about a pivot.The pivot may be fused to the tubing. The clamp may be biased to crimpthe compressible portion of the tubing. The clamp may be positioned tocrimp the compressible portion of the tubing flush with an inner lumenof the blood vessel.

The graft may include a sleeve that positions the clamp to crimp thecompressible portion of the tubing flush with an inner lumen of theblood vessel. The graft may include a sleeve. The sleeve may includethree walls. The sleeve may be open on a fourth side to receive an armof the clamp. The three sides of the sleeve may be formed from an outerwall of the tubing, material extending substantially parallel to theouter wall of the tubing and material extending substantiallyperpendicular to the outer wall of the tubing. When an angularanastomosis is deployed, the third wall may be formed from material thatis substantially parallel to a longitudinal axis of the conduit.

In some embodiments the clamp may include two or more rotatable arms. Insome embodiments, the graft may include two or more sleeves to hold twoor more arms of the clamp.

For example, the graft may include a second sleeve constructed from theouter wall of the tubing, second material extending substantiallyparallel to the outer wall and second material extending substantiallyperpendicular to the outer wall of the tubing.

Closing the clamp on the compressible portion of the tubing may crimpthe tubing. Crimping the tubing may result in a collapse of a lumen ofthe tubing. Collapsing the lumen of the tubing may prevent fluid fromexiting or entering the tubing.

The graft may include a balloon. The balloon may be positioned insidethe clamp. The balloon may be positioned about the non-compressibleportion of the tubing.

The balloon, when inflated about the non-compressible portion of thetubing, may rotate the clamp about the pivot, opening the clamp andreleasing the clamp from the compressible portion of the tubing. Uponbeing released from the clamp, the compressible tubing may return to anexpanded state forming a lumen within the tubing. After expanding, thelumen may receive or transmit fluid.

The graft may include an elastic band that biases the clamp to crimp thecompressible portion of the tubing. The elastic band may encircle firstand second rotatable arms of the clamp. The elastic band may be anO-ring. The clamp may be biased using any suitable biasing member. Forexample, the clamp may be biased with a clip having a “memory” for acertain shape. The clip may be constructed from plastic or metal anysuitable material. For example, the clip may be constructed fromNitinol, a memory shape alloy.

The tubing may be a first tubing. The graft may include a second tubing.The second tubing may include inflatable material encircling the firsttubing. The inflatable material may be the balloon. In some embodiments,the inflatable material may be crimped to seal fluid within the secondtubing. In some embodiments, a plug may encircle the first tubing andseal fluid within the second tubing.

Sealing the fluid within the second tubing may force the balloon toinflate in response to pressurizing the second tubing. The second tubingmay be pressurized by the moveable platform compressing a bladder in thereservoir. Compressing the bladder may expel fluid from the bladder intothe second tubing.

The plug may include a flange. The flange may be circular. The flangemay be configured to mate with a corresponding indent in the clamp. Themating of the flange and the indent may fix a position of the clamprelative to the blood vessel. The mating of the flange and the indentmay fix a position of the clamp along a longitudinal axis of the tubing.The mating of the flange and the indent may fix a position of clampabout the longitudinal axis of the tubing.

Methods may include accessing a blood vessel via a graft anastomized tothe blood vessel. The method may include inserting a needle through aseptum of a subcutaneous reservoir. The methods may include expanding afirst chamber of the subcutaneous reservoir by pressing the needleagainst a moveable platform. The moveable platform may fluidly seal thefirst chamber from a second chamber of the reservoir.

The methods may include generating hydraulic pressure by compressing themoveable platform against a liquid-filled bladder housed within thesecond chamber. Using the hydraulic pressure, the methods may includeopening a clamp. The clamp may be biased to compress a resilient segmentof tubing anastomized to the blood vessel. Compressing the resilientsegment of the tubing may collapse a lumen of the tubing. When the clampis opened, the resilient segment of the tubing may expand, reopening thecollapsed lumen.

The methods may include directing blood, via the resilient segment oftubing, from the blood vessel to the first chamber of the reservoir.Methods may include extracting the blood from the first chamber. Theblood may be extracted using the needle inserted through the septum intothe first chamber.

The graft may be a first graft. The subcutaneous reservoir may be afirst subcutaneous reservoir. The methods may include transferring bloodextracted from the first subcutaneous reservoir to a dialysis machineand filtering the blood. The filtered blood may then be transferred to asecond subcutaneous reservoir. The methods may include reintroducing thefiltered blood to circulation via a second graft.

The first graft may be anastomized to an artery. The first graft may beanastomized to a vein. The second graft may be anastomized to a vein.The second graft may be anastomized to an artery. In some embodiments, aplurality of grafts may be implanted. Each of the plurality of graftsmay be anastomized to one or more blood vessels.

Methods may include locking the moveable platform at a distance from theseptum. The locking the moveable platform may maintain a threshold levelof hydraulic pressure. The threshold level of hydraulic pressure maykeep the balloon inflated and the clamp open.

Pressure may be applied to the needle to press the needle against themoveable platform to unlock the moveable platform. Unlocking themoveable platform may allow a biasing member inside the reservoir tocollapse the first chamber of the subcutaneous reservoir. Collapsing thefirst chamber may allow the bladder to inflate, thereby reducing thehydraulic pressure transmitted to the balloon. The loss of hydraulicpressure may deflate the balloon allowing the biasing member of theclamp to close the clamp upon the resilient segment of tubing and sealthe blood vessel from the graft.

The method may include positioning the clamp so that outer walls of theresilient tubing are sealed flush with each other. Sealing the resilienttubing in this manner may allow the blood vessel to maintain a uniformor substantially uniform blood flow through the blood vessel across theanastomization site after the closing of the clamp. The uniform bloodflow may correspond to a native blood flow through the vessel.

In yet another embodiment of a subcutaneous vascular access device,there are basically three preferred elements a needle receptor, a devicelumen, and lumen clamping means. The needle receptor is subcutaneouslylocated while portions of the clamping means lies deeper; the devicelumen is the physical connection between the subcutaneous portions ofthe device and the deeper portion of the device, it also provides fluidcommunication between the needle receptor and a native body lumen.Similarly, the portions of the lumen clamping means that are meant to beactuated by hand (preferably with two fingers) are subcutaneous, whilethe portion contacting the device lumen are arranged to be deeper, suchthat the orientation provides an effective seal without creating anyclotting or turbulent flow potential. This improved sealing method istargeted to reduce neo-intimal hyperplasia and stenosis formationcommonly associated with aberrant vascular geometry caused bynon-uniform device lumens or device protrusions which cause turbulentblood flow. Many anastomotic devices do not create a uniform surface atthe area they serve to seal, thus creating pockets of stagnant blood, oreddies in the blood flow path or contiguous with the blood stream.

The needle receptor will optimally be palpable and located just beneaththe skin surface. At the distal tapering aspect of each needle receptoris basically funnel shaped geometry, and In one embodiment, there willbe a ball-valve mechanism, where the act of physically inserting thedialysis needle into, and through, the funnel will supply the requiredforce to open the ball-valve mechanism and simultaneously allow thedialysis needle to pass through the funnel and into the blood lumen. Inanother embodiment, the needle receptor provides a funnel shapedgeometry, having an elastic sealing material at or near narrowed end ofthe funnel. The elastic sealing material is configured to serve as asealing ring. The sealing material is provided with an opening throughwhich a displaceable sealing rod would be inserted to block unwantedflow through the opening. Upon insertion of the needle through thefunnel shaped needle receptor, and through the opening of the sealingmaterial, the advancing needle displaces the sealing rod, for example,either compressing the rod axially, or urging the rod against acompressible material, such where the sealing rod is supported by aspring, or spring loaded member, and upon the rod being displaced by theneedle, as it is advanced, compresses the spring or collapsible rod.With the needle in place within the needle receptor, the clamp on thelumen may be opened to allow fluid flow through the lumen, and dialysis(or other procedure) may be performed so long as the needle remains inplace. Upon the needle being removed from the funnel shaped element ofthe needle receptor, the sealing rod will be urged, such as by thecompressed spring, and again be directed through the opening in thesealing material vacated by the withdrawn needle. In this manner, as theneedle is removed from the funnel, the sealing rod fills the opening andfluid flow will be blocked from entering or exiting through the funnel.Thus, in the event of needle removal, prior to the clamp on the lumenbeing shut, the sealing rod will be urged back to the initial positionand fill the opening left by the needle in the sealing material. The rodthus serves as safety seal to prevent undesirable free flow of fluid outfrom the lumen in the event of premature needle withdrawal.

For the various embodiments described herein, optimally, there will bemultiple locations for directing a needle into the needle receptor, atdistinct positions. For example, providing two needle entry points, mayallow the access to be sequenced through each, in order to promote skinhealing between being accessed.

In an embodiment, the blood lumen at the needle entry site will be rigidbut penetrable, so as to maintain good patency and resilience todeformation. As the needle is advanced, the opening is increased enoughto allow for the needle but not for blood leakage. When the needle(e.g., a dialysis needle) is removed the ball-valve mechanism willrotate back into a closed position sealing the blood lumen from thecylindrical portion of the funnel. The blood lumen will optimally havean almost spherical cross section configuration so that blood cannotsettle into any corner

For the various embodiments described herein, the clamp is optimallylocated where the anastomosis between the device lumen and native vesselis located. The clamp runs substantially parallel to the long axis ofthe native vessel in the form of two rod-like members that flank thedistal most aspect of the device lumen, optimally at a positionimmediately above the anastomosis with the native vessel (for the sakeof this description, the distal end of the device lumen and theanastomosis site may be considered one and the same when discussing theclamping location form and function). The rods will be connected to oneanother, at one end, such that in the closed position, they compress thedistal end of the device lumen preventing blood from entering andstagnating in the device lumen. The clamp is further designed tominimize the blood exposure to the device's blood lumen to optimize fornearly laminar blood flow in the native lumen when the clamp is closedand the device is not in use. When the clamp is opened, blood will enterthe device lumen through the anastomosis. The clamp is opened using theforce generated by the fluid driven member of the device, oralternatively by mechanical linkages transmitting forces applied topalpable elements placed subcutaneously, as will be discussed.

In an embodiment relying on hydraulic fluid for transmitting forces,this fluid driven member is noted by a fluid filled tube in closeproximity to the device lumen, a gear mechanism (or other force transfermechanism), a plunger and optimally a safety mechanism. Just beneath theskin surface, in an embodiment, there is a palpable section with twosemicircular halves. When both halves are depressed simultaneously,attached gear ring(s) will interact with corresponding cylindricalgears. As the gears rotate they rotate a screw like plunger within thehydraulic tube. The inner lining of the hydraulic tube, in which thescrew plunger resides, is also threaded. When the screw plunger isrotated clockwise it moves forward and vice versa. As the plunger movesforward, it will create the hydraulic pressure that engages a secondplunger to drive a wedge like member which serves to open the “clamp”section of the device.

In an embodiment relying on mechanical linkages for transmitting forces,there are provided on the device implanted subcutaneously, one or moretabs that are palpable through the skin, and configured to bemanipulated by the user by applying pressure to the one or more tabs.The movement of the one or more tabs, are configured to actuate viamechanical linkages, preferably levers, the clamp to open the lumen forfluid flow therethrough. Additionally, the mechanical linkages areconfigured to cause movement of at least a portion of the needlereceptor, thereby applying a compressive force to the elastic sealingmaterial, whereupon the sealing material will be squeezed tightlyagainst the outside surface of the needle. The movement of the clamp andthe movement of the needle receptor may be proportional or indirectlyproportional to the movement of the one or more tabs. Through mechanicallinkages, such as those depicted in the various embodiments containedherein, the movement of the one or more tabs will effect a movement of aclamp puller, which in turn pulls a tension element attached to theclamp elements, thereby causing the clamp to open. The linear movementof the clamp puller is greater than the linear movement of the one ormore tabs; while the linear movement of the needle receptor portionagainst the sealing material will be less than the linear movement ofthe one or more tabs. The linear movement of the needle receptor portionagainst the sealing material is preferably less than that of the tabmovement, as a result of the creation of mechanical advantage, to applya greater compressive force over a shorter travel, using techniquesknown to those skilled in the art. In this manner, the device isconfigured to apply a compressive force to the sealing material,creating mechanical advantage in order to apply a compressive force, asis known to those skilled in the art, where the force will be able todeform the sealing material in order to create the seal. For thisembodiment of the device having mechanical linkages to effectuate clampactuation and compression of the sealing material, it is contemplatedthat the linear movement of the tabs will be in the range of 1-5millimeters, preferably in the range of 2-4 millimeters, and morepreferably 2-3 millimeters. From this tab movement, it is anticipatedthat the linear action of the clamp puller to open the clamp will be atleast 150%, at least 200%, or at least 300% of the movement of the tabs;while the movement of the needle receptor will be in the range of lessthan 50%, less than 30%, or less than 20% of the movement of the tabs.

In an embodiment, there are optimally additional rings attached to thesemicircles that engage a “pen click” mechanism along the cylinder withthe force used to open the clamp, thereby allowing continual blood flowthrough the device lumen. To close the clamp, the operator presses thesemicircles again, releasing the “pen click” mechanism, allowing theclamp to close. The retraction of the semicircles rotates the gears inthe hydraulic generator section of the device unscrewing the screwplunger backward and reducing the hydraulic force exerted on the seconddistal plunger. The clamp and wedge assembly will force the secondplunger backward thereby sealing the anastomosis.

In the various embodiments described herein, there may be a safetymechanism on the device to prevent the clamp from being inadvertentlyopened. In one embodiment, the safety mechanism is comprised of asubcutaneous button which retracts a pin when compressed. The pin runsparallel within a conduit contained within the wall of the device lumen,or other convenient location. The pin prevents the semicircle gear ringfrom rotating around the blood lumen cylinder when not retracted. Whenthe subcutaneous safety button is compressed, it retracts the pincompletely into the wall of the blood lumen cylinder allowing the gearring to rotate. In order to open the device clamps, the operator has topress and hold the safety button and then compress the semicircles.

In another embodiment, the safety mechanism comprises a subcutaneouslylocated, palpable button, and similar to the previously described “penclick” mechanism, the palpable button may be manipulated to alternatebetween a first state and a second state. While in a first state, thepalpable button prevents movement of the one or more tabs, therebypreventing the clamp sealing the lumen from opening; and while in asecond state, the palpable button frees the one or more tabs foractuation, such that the clamp can be opened. Preferably, the palpablebutton, in a first state, serves to prevent substantially all movementof the subcutaneous tabs, until such a point as the button has beendepressed. Once the palpable button is depressed, and is in the secondstate, the one or more tabs may then be pressed to cause the clamp toopen and the palpable button, while in the second state is furtherarranged to maintain the one or more tabs in the actuated position, andthereby ensures the clamp remains in an open state, until such a pointin time at which the palpable button is depressed again, and caused torevert to the first state, whereupon multiple actions occur: the one ormore tabs are released, causing the clamp on the lumen to be closed byspring tension as the clamp puller returns to its original location; thefunnel portion moves away from the sealing material, and halts thecompression upon the sealing material, thereby releasing the sealgrasping the needle in the funnel is released, whereupon the needle maybe withdrawn.

In the use of this embodiment of the device, it is contemplated that theoperator will direct a hollow needle to penetrate the skin, andsubcutaneously enter the wide mouth end of the funnel shaped element ofthe needle receptor. As the needle is advanced deeper into the needlereceptor, it advances through an opening in a sealing materialpositioned at or near a narrowed portion of the funnel of the needlereceptor. As the needle is advanced through the opening in the sealingmaterial, it displaces a sealing rod that is aligned coaxially with theaxis of the needle receptor. The needle is arranged along an axis thatextends through the center of the funnel and extends tangentially to aspherical chamber within the device. The spherical chamber is in fluidcommunication with a lumen extending distally towards the anastomosisjunction. The needle is advanced along the axis until the distal tip ofthe needle is in fluid communication with the interior of the sphericalchamber. In an embodiment, the needle is advanced to the location wherethe distal tip of the needle located tangential to or is aligned with atangential opening into the interior of the spherical chamber. At thispoint, the palpable button of the safety mechanism may be depressed.With the palpable button depressed, in a manner similar to a “penclick”, the safety mechanism will now allow the user to manipulate atleast one tab, preferably two tabs, by applying a pressure and causingmovement of the tab. The movement of the one or more tabs will cause theaction of mechanical linkages, which result in the actuation of theclamp adjacent to the anastomosis junction to open, and also cause atleast a portion of the funnel of the needle receptor to move in a distaldirection, whereupon compressive force is applied the sealing material.The sealing material is thus squeezed between the housing of the deviceand the funnel, and in response, the sealing material constricts theopening through which the needle is directed, thereby sealing tightlyaround the outside surface of the needle, and thereby preventing fluidflow around the periphery of the needle. The movement of the one or moretabs is restrained by the safety mechanism, allowing the user to releasethe pressure of the tabs, and have the tabs retain their actuatedposition. In this manner, the clamp is maintained open, allowing fluidflow through the lumen, and maintaining the seal around the needle.

In use of the embodiment of the device having the tab actuated clamps,it is contemplated that two or more of these devices may be placed fordialysis. In this instance, it is anticipated that dialysis would occurwhere each device is implanted and anastomosed to a blood vessel, wherefirst device is in fluid communication with the needle that serves towithdraw blood, typically from the arterial system, from the patient forthe dialysis procedure, and the second device is in fluid communicationwith the needle that is returning dialyzed or filtered blood to thepatient, typically into the venous system. Upon completion of thedialysis treatment, the fluid line for each device would be flushed withan amount of saline, or any other suitable flushing liquid to clear theline. After flushing, the palpable button of the safety mechanism maythen be depressed, thereby returning the tabs to their original stateand sealing the lumen by closing the clamp at the anastomosis junction,and further releasing seal of the sealing material around the peripheryof the needle, such that the needle may then be withdrawn. As the needleis withdrawn from the needle receptor, the sealing rod, which had beendisplaced by the advancing needle, will return to its original positionwithin the sealing material, thereby preventing fluid transfer in or outthrough the funnel of the needle receptor.

In the event that the needle is removed from the patient duringdialysis, the sealing rod would be urged proximally into the opening inthe sealing material left by the removal of the needle, therebypreventing the free flow of fluid through the device. This is especiallyimportant where the lumen is anastomosed to the arterial system, as theblood pressure is higher than in the venous system, and would if leftunchecked, potentially cause significant blood loss to the patient. Thusthe embodiment of the device featuring a sealing rod provides anautomatic safety seal to prevent unchecked flow through the device inthe event that the needle is removed while the clamp remains in an openposition, and there is fluid communication between the needle receptorand the blood vessel.

In another embodiment, the subcutaneous vascular access device,comprises a needle receptor, a lumen (which may be referred to as adevice lumen, in order to distinguish the element from a native bodilylumen), a lumen clamping means, and a clamp manipulator (In certainorientations, the clamp manipulator may be referred to as a component ofthe lumen clamping means, which is just for ease of illustration). Inthese types of embodiments said needle receptor is arranged to accept aneedle having a distal tip that is inserted from outside the body, andto provide positioning means for the placement of said needle.

In an embodiment, the lumen is arranged to contact said needle receptorat a first location and with said lumen being arranged to be anastomosedto a native body lumen at a second location. The lumen is furtherdesigned to have a cross section that remains nearly circular, but othershapes may be utilized so long as no geometric feature provides an eddyor other stagnate region, as this may lead to clotting or other cascadesof difficulties. Similarly, irregularities in the vessel wall that causeturbulent or otherwise irregular flow will cause a different set ofproblems; all of which will decrease the efficiency of the device,render it unusable, or harm the patient in a worst case situation.

For the various embodiments described herein, The lumen clamping meansgenerally comprises at least two clamping members. These members areoptimally arranged to compress said lumen at a location between saidfirst location and said second location, in an orientation substantiallyparallel to said lumen. It is believed that a parallel orientation isoptimal, however, it is contemplated that lumen characteristics(including anastomosis design and characteristics) and fluid mechanicsmay dictate that a slight offset from parallel may provide a better sealwith optimal flow characteristics. Therefore, a range of clamporientations are contemplated in this disclosure. The goal of thiselement is primarily to provide a seal along said anastomosis andprohibit fluid flow therethrough, while maintaining an even flow ofblood or other fluid through the native body lumen.

The shape of the clamping members may be generally circular incross-section, to provide a linear region of highest clamping stress;however, lumen design and materials may dictate that a square orrectangular cross-section may provide an optimum sealing profile.Therefore, these and various contacting shapes are within thecontemplation of this disclosure.

In an embodiment relying on hydraulic operation, a fluid driven member,or other suitable member arranged to transfer the forces applied, may beutilized to be energized and cause diametrically opposed motion of thesaid at least two clamping members thereby decompressing said lumen toprovide fluid communication between said native body lumen and saidfirst location. The fluid used herein, may be a liquid or a gas,however, the noncompressibility of a liquid may provide a rapid andrepeatable response.

In another embodiment, a clamp manipulator, also referred to as a clampmanipulator or manipulation means, may be used. In an embodiment, theclamp manipulator may comprise elements that actuate mechanical linkageswhich directly drive the opening of clamp, and actuate a sealingmechanism around a needle, as has been previously discussed. Forexample, the action of the clamp manipulator may occur as one or moretabs are pressed by the user, the tabs through mechanical linkagesconvert the movement to a linear movement of a clamp puller, which isconnected by a tension element to the clamping members, which react byopening and unsealing the lumen to allow fluid flow therethrough. In anembodiment, the clamp members are spring held by spring tension in aclosed position, unless the clamp puller is retracted with a force toovercome the spring tension. Additionally, the one or more tabs whenpressed, are urged against a spring, such that upon release, the springtension pushes the tabs back to their original state, and reversing themovements caused by the action of the one or more tabs. In anotherembodiment, the clamp manipulator may comprise at least one tabrotatably attached to at least one axial support member, wherein thedepressing of said tab causes rotation which may serve to engage a gearassembly which is arranged to pressurize a fluid to drive said fluiddriven member.

In various embodiments described herein, the aforementioned clampmanipulator may further comprise at least a second tab. For theembodiment having hydraulic operation, the second tab may be rotatablyattached to a second axial support member. For the embodiment relying onmechanical linkages to actuate the clamp, the second tab is preferablyarranged to operate in concert with the first tab, such that the tabsmay be squeezed towards each other, and the movement of each tabs arecoupled together to reduce the force that each tab would have to exertalone to perform the tasks of opening the clamp, and tightly sealingaround the needle, as has been described previously. Regardless, ofwhether a single or dual tab assembly is used, the tab or tabs arearranged to allow two fingers to provide adequate force to effect therequired actions, such as clamp opening and sealing. It is contemplatedthat for a multiple tab assembly, each tab may be arranged to operateindependently, or alternatively perform dissimilar actions. For example,a first tab may be configured to actuate the clamp, and the second tabmay actuate the sealing around the needle. The clamp manipulator mayfurther comprise locking means, wherein said locking means secures saidtab(s) at a predetermined amount of travel. Additionally, a preferredembodiment locking means is arranged to unlock following the applicationof additional pressure to said tab(s) while they are in the securedstate. This tab, or arrangement of tabs, are preferably palpable fromoutside the body.

In an embodiment, the needle receptor, and more precisely, thepositioning means, may include a rotating member. This rotating membermay also include an angular protrusion arranged to slidably accept thedistal tip of said needle, wherein said angular protrusion moves uponthe application of force from said needle which causes rotation of saidrotating member. The rotating member may also contain a channel arrangedto accept said needle following the alignment of said channel with saidneedle which was caused by the rotation of said rotating member. Oncethe rotating member is turned far enough by the needle tip, the channelbecomes proud, and then such needle slides into the channel. The needlewill complete the alignment with the channel as it begins to slide in.In a preferred embodiment, the needle fits tightly against the channel,causing a seal to be formed between the needle and the channel. Once theneedle is lodged in said channel, the needle and the channel are influid communication with said device lumen. To better assess needleplacement, meaning the situs of the initial needle stick from outsidethe body, the needle receptor is preferred to be palpable from outsidethe body.

The rotating member may be further arranged to have resistance torotation, whereupon said rotating member provides return rotation forceduring needle insertion; wherein said return rotation force serves togrip said needle and prevents migration of the distal tip of said needleduring a procedure. This return force may also aid in creating andholding the seal between the needle and the channel. These variousembodiments containing needle receptors, further comprise a plurality ofneedle receptors, with said receptors being located longitudinally alongsaid lumen such that said needle may be introduced at a plurality oflocations.

In yet another embodiment of a subcutaneous vascular access device,there are basically four preferred elements a device lumen, a needlereceptor, lumen clamping means, and a clamp manipulator. In thisembodiment the device lumen has a distal end and a proximal end defininga lumen length. The device lumen may also have an anastomosis at saiddistal end, wherein said anastomosis serves to connect said device lumento a native body lumen.

A needle receptor may be arranged to be palpable from outside the bodyand anchored along the lumen length to provide fluid communicationtherewith; further, the needle receptor may have a rotating memberarranged within its base. The rotating member may, among other thingsserve to adjustably constrain the flow of fluid from said device lumeninto said needle receptor.

The rotating member may accomplish this preferred action through theincorporation of an angular protrusion arranged to slidably accept thedistal tip of a needle, wherein said angular protrusion moves upon theapplication of force from said needle which causes rotation of saidrotating member. Additionally, a channel may be arranged to accept saidneedle following the alignment of said channel with said needle upon theappropriate amount of rotation of said rotating member, whereupon saidneedle and said channel become aligned and thus are in fluidcommunication with said lumen. The entry needle may be assisted orguided, in this embodiment, by a funnel shaped entry port arranged toaccept and guide said needle toward said rotating member. Further, thefunnel shaped entry port may be palpable, so that the needle stick inthe skin may be more exact.

A preferred embodiment will also contain a lumen clamping means arrangedat the proximal end of said device lumen. This lumen clamping means mayinclude a manipulation means comprising two tabs each rotatably attachedto a main axis member. Further, a pressure translation assemblycomprising gearing means may be arranged to couple with saidmanipulation means upon the rotation of said tabs. This gearing meansmay consist of at least one external-tooth ring-gear rotatably attachedto the outer circumference of the device lumen. In a preferredembodiment, the device contains two such ring-gears; with eachseparately coupled to one of two tabs. The coupling could be maintainedby a ratcheting type of mechanism, or other gear transition mechanismknown to those skilled in the art. This embodiment may also benefit fromtwo follower-rings, which could be similarly rotatably attached to theouter circumference of the device lumen. These rings may be located atthe opposite end of the tab, away from the ring-gear, in order toprovide support or lateral stability to the tab (especially during use).The follower-rings are preferred to be smooth on the inner and outersurfaces, in order to allow free rotation.

In an embodiment the gear-rings are each coupled to a slave gear; sincethe gear-rings are attached to the tabs (which travel in oppositedirections) the two slave gears travel in opposite directions, andtherefore they will mesh. These slave gears act in concert to add thecumulative power generated by the tabs. The tangential tab rotation maybe translated into longitudinal movement through the use of a fluiddriven member. The fluid driven member may be arranged to be driven byone of the slave gears. An alternate embodiment may further utilize alongitudinal screw gear coupled with said gearing means.

In an embodiment, the fluid driven member may be preferably constructedwith a fluid housing tube arranged to contain a pressurized fluid,having a first end and a second end. A plunger arranged within saidfirst end of said fluid housing tube may be further arranged to receivesaid longitudinal screw gear or a plunger drive by said slave gearaffixed thereto. In this embodiment, the plunger serves to modulatepressure in the fluid housing tube.

The fluid driven member may be oriented longitudinally with the mainaxis of the device lumen, and serve to translate power in thatdirection. A wedge member is preferably slidably arranged at said secondend of said fluid housing tube, wherein the wedge member moves distallywith increasing fluid pressure.

In the various embodiments described herein, at least two clampingmembers arranged to rest in tension on opposing sides of said devicelumen. In the embodiment using hydraulic forces, the clamping membersare further arranged to receive said wedge member such that said wedgeserves to translate the longitudinal movement imparted by saidpressurized fluid into lateral forces. These lateral forces operate toseparate said at least two clamping members, with such separationallowing the device lumen to gain fluid communication with said nativebody lumen. The clamping members may be arranged with an angularreceptor, concave in nature and formed by one member on each clamp beingangularly oriented with the device lumen's longitudinal axis.

Apparatus and methods described herein are illustrative. Apparatus andmethods of the invention may involve some or all of the features of theillustrative apparatus and/or some or all of the steps of theillustrative methods. The steps of the methods may be performed in anorder other than the order shown and described herein. Some embodimentsmay omit steps shown and described in connection with the illustrativemethods. Some embodiments may include steps that are not shown anddescribed in connection with the illustrative methods.

Illustrative embodiments of apparatus and methods in accordance with theprinciples of the invention will now be described with reference to theaccompanying drawings, which form a part hereof. The drawings showillustrative features of apparatus and methods in accordance with theprinciples of the invention. The features are illustrated in the contextof selected embodiments. It will be understood that features shown inconnection with one of the embodiments may be practiced in accordancewith the principles of the invention along with features shown inconnection with another of the embodiments.

The apparatus and methods of the invention will be described inconnection with exemplary embodiments. It is to be understood that otherembodiments may be utilized and structural, functional and proceduralmodifications may be made without departing from the scope and spirit ofthe present invention.

FIG. 1 shows illustrative therapeutic scenario 100.

Scenario 100 shows limb 105. Limb 105 includes vein 103 and artery 101.Scenario 100 shows access port 107. Port 107 is affixed to artery 101.Port 107 may be affixed to any suitable blood vessel, such as vein 103.Port 107 may be affixed to artery 101 using a surgical technique. Thesurgical technique may include anastomosis and arteriotomy/venotomy. Theanastomosis may be an end-to-end straight anastomosis. The anastomosismay include an end-to-end angled anastomosis. The anastomosis mayinclude a side to end or side to side anastomosis. The angledanastomosis may be “bulbous.” An angled anastomosis may maintain laminarflow and reduce turbulence of blood flowing through blood vessel 101 or103. Any suitable techniques may be used to affix port 107 to a bloodvessel 103 or 101.

Port 107 is coupled via tubing 111 to reservoir 109. Tubing 111 mayallow access to “deep” blood vessels. Reservoir 109 may be affixed tolimb 105 subcutaneously. Reservoir 109 may be configured to receive oneof feeds 113. Feeds 113 draw blood from a blood vessel. Feeds 113 mayterminate in a needle or any other suitable connection to reservoir 109.For example, the feeds may terminate in a 14-gauge needle. Feeds 113transfer blood to dialysis machine 115. Feeds 113 transfer bloodextracted from blood vessel 101 to dialysis machine 115. Dialysismachine 115 may filter the blood extracted from blood vessel 101.Dialysis machine 115 may return filtered blood to blood vessel 103 viafeeds 113.

In some embodiments, a system including reservoir 109, tubing 111 andport 107 may be affixed to vein 103. Reservoir 109 may receive filteredblood from dialysis machine 115 via feeds 113. The filtered blood may bepumped through reservoir 109, through tubing 111 and returned tocirculation in blood vessel 103 through port 107.

One or more components of reservoir 109 may seal tubing 111 and port107. Sealing tubing 111 and port 107 may not allow blood to flow fromblood vessel 101 into port 107 or tubing 111. Reservoir 109 may beconfigured to sequentially seal tubing 111 prior to or after sealingport 107.

FIG. 2 shows illustrative apparatus 200. Apparatus 200 may include port202. Port 202 may include one or more of the features of port 107 (shownin FIG. 1). Port 202 may be in fluid connection with tubing 204. Tubing204 may include one or more features of tubing 111 (shown in FIG. 1).Tubing 204 may be in fluid connection with reservoir 206. Reservoir 206may include one or more reservoirs such as reservoir 223 and reservoir231. Reservoir 206 may include one or more features of reservoir 109(shown in FIG. 1).

Port 202 may include housing 201. Housing 201 may be constructed fromsolid non-thrombogenic plastic or any suitable materials. Exemplarysuitable materials may include Dacron, Gore-Tex, polytetrafluoroethylene(“PTFE”), fluoropolymer products and any material suitable forimplantation in a human body. Suitable material may include materialapproved by a government agency, such as the United States Food and DrugAdministration, for use in a human body.

Port 202 may include swing-arm 203. Swing-arm 203 may be constructedfrom and/or coated with Dacron, Gore-Tex, PTFE, fluoropolymer productsor any suitable material. Swing-arm 203 may rotate about hinge 233.Hinge 233 may be constructed from a pliable Dacron, Gore-Tex, PTFE,fluoropolymer products or any suitable material. Swing-arm 203 may beconfigured to rotate about hinge 233 and allow blood to flow betweenblood vessel 243 and housing 201. Blood may flow from blood vessel 243into housing 201. Blood may flow from housing 201 into blood vessel 243.Swing-arm 203 may be configured to rotate about hinge 233 and impedeand/or cut-off blood flow between blood vessel 243 and housing 201.

Swing-arm 203 may be configured to rotate about hinge 233 in response inan increase in pressure inside chamber 205. Chamber 205 may be anysuitable shape. Chamber 205 may be circular, square or triangular.Chamber 205 may be in fluid connection with lumen 209. Lumen 209 may bein fluid connection with chamber 229.

Needle 227 may inject a medium into chamber 229. The medium maypreferable be a liquid, such as a saline solution. The medium mayinclude any suitable liquid or gas. Adapter 236 prevents a leakage ofmedium flowing between lumen 209 and chamber 229. Adapter 241 prevents aleakage of the medium flowing between lumen 209 and chamber 205.Adapters 236 or 241 may be any suitable adapter. For example, an adaptermay hermetically seal lumen 209 and chamber 229. The adapter may includea threaded screw.

Injecting the medium into chamber 229 may force the medium through lumen209 and into chamber 205. Forcing the medium into chamber 205 mayincrease a pressure inside chamber 205. The increased pressure insidechamber 205 may cause swing-arm 203 to rotate about hinge 233. Rotationof swing-arm 203 about hinge 233 may “push” swing-arm 203 toward bloodvessel 243. Pressure in chamber 205 and rotation of swing-arm 203 abouthinge 233 may result in swing-arm 203 sealing housing 201 from bloodflowing through blood vessel 243.

Needle 227 may inject the medium until a threshold pressure inside lumen205 is obtained. Needle 227 may include a pressure gauge (not shown).The threshold pressure may correspond to a degree of rotation ofswing-arm 203 about hinge 233. The threshold pressure may correspond toa positioning of swing-arm 203 about hinge 233 such that swing-arm 203is substantially parallel to blood vessel 243. The threshold pressuremay correspond to a positioning of swing-arm 203 about hinge 233 suchthat blood does not flow into housing 201.

Reservoir 231 includes membrane 225. Membrane 225 may be a self-sealingmembrane. Needle 227 may inject the medium into reservoir 231 bypenetrating self-sealing membrane 225. After a registering of athreshold pressure, needle 227 may be withdrawn through self-sealingmembrane 225. Self-sealing membrane may prevent any medium leakage afterwithdrawal of needle 227. Self-sealing membrane 225 may maintain thethreshold pressure until a portion of the medium is extracted fromchamber 229.

Needle 227 may extract a portion of the medium from chamber 229.Extracting a portion of the medium may adjust the threshold pressure.Extracting a portion of the medium may adjust pressure on swing-arm 203.Extracting the portion of the medium may reduce the threshold pressureimposed on swing-arm 203. Extracting the portion of the medium mayimpose a negative pressure on swing-arm 203. The negative pressure mayresult in swing-arm 203 rotating about hinge 233. Rotation of swing-arm203 may contract chamber 205.

Extracting the portion of the medium may open housing 201 to bloodflowing within blood vessel 243. Extracting at least a portion of themedium from reservoir may result in swing-arm 203 rotating about hinge233. The rotation of swing-arm 203 about hinge 233 may unseal an orificebetween housing 201 and blood vessel 243. Rotation of swing-arm 203about hinge 233 may allow blood to flow from blood vessel 243 intohousing 201. The blood may flow from blood vessel 243 into passageway207. A pressure exerted on blood within blood vessel 243 may force theblood into lumen passageway 207. The pressure may be arterial bloodpressure. Blood within passageway 207 may flow into lumen 211. Adapter239 may join passageway 207 and lumen 211. Adapter 239 may preventleakage of blood flowing between passageway 207 and lumen 211.

Reservoir 223 includes chamber 213. Reservoir 223 includes membrane 215.Membrane 215 may be a self-sealing membrane. Chamber 213 may be expandedor contracted by movement of platform 219. Platform 219 may be rigid.Platform 219 may be biased relative to self-sealing membrane 215 bysprings 221. Platform 219 may be biased using any suitable pressureexerting member. A pressure exerting member may include elasticmembranes and springs. Platform 219 may be biased to contract chamber213. Platform 219 may be biased to exert pressure on self-sealingmembrane 215.

Needle 217 may penetrate self-sealing membrane 215. Needle 217 may be influid connection with feeds 113 (shown in FIG. 1). Needle 217 may pushplatform 219 away from self-sealing membrane 215. Movement of platform219 away from self-sealing membrane 215 may expand chamber 213.Expanding chamber 213 may allow blood to flow from lumen 211 intochamber 213. Lumen 211 may be joined to reservoir 223 by adapter 235.Adapter 235 may provide a leak-proof connection between chamber 213 andlumen 211. Adapter 235 may provide a hermetical connection betweenchamber 213 and lumen 211.

Needle 217 may extract blood from chamber 213. Blood extracted fromchamber 213 may be transferred to dialysis machine 115 (shown in FIG.1). Blood extracted from chamber 213 may be filtered by dialysis machine115.

Needle 217 may inject blood into chamber 213. Blood injected intochamber 213 may be reintroduced into circulation by travelling throughlumen 211, through passageway 207 and into blood vessel 243.

Chamber 213 may include internal walls 247 and 245. Walls 247 and 245may be flexible. Walls 247 and 245 may be constructed from Dacron,Gore-Tex, PTFE, fluoropolymer products or any other suitable material.Walls 247 and 245 may allow for expansion and/or contraction of chamber213. Walls 247 and 245 may prevent blood from leaking out of chamber213.

When needle 217 is removed from self-sealing membrane 215, springs 221may exert pressure on platform 219. The pressure may “push” platform 219toward membrane 215. Movement of platform 219 may purge blood or anyother medium present in chamber 213.

Following a purging of chamber 213, lumen 211 may be sealed. Lumen 211may be sealed by injecting a medium into chamber 229. Injection of themedium may increase pressure inside lumen 209. The increased pressuremay result in a diameter of lumen 209 expanding. Expansion of lumen 209may decrease a diameter of lumen 211. Expansion of lumen 209 may seallumen 211. Lumen 209 may be configured to expand faster proximal toreservoir 223 and more slowly proximal to housing 201. Bendingresistances of tubing 204 may vary longitudinally along lumen 209. Thedifferent expansion rates may “squeeze” any residual medium present inlumen 211 into passageway 207.

Apparatus 200 may be configured to allow for a full expansion of lumen209 and corresponding sealing of lumen 211 prior to a sealing ofpassageway 207. Sequential sealing may allow any residual medium presentin lumen 211 to be “squeezed” through lumen 211 and through passageway207 before sealing passageway 207. Continuous injection of medium intochamber 229 may seal lumen 211 and passageway 207. Completion of thesealing of lumen 211 and passageway 207 may correspond to a registeringof a threshold pressure inside chamber 229.

In some embodiments, tubing 204 may be fused to reservoir 206. Fusingtubing 204 and reservoir 206 may allow residual medium to be “squeezed”out of a juncture between tubing 204 and reservoir 206. Some embodimentsmay not include tubing 204. For example, reservoir 206 may be fuseddirectly to port 202.

Components of apparatus 200 may be sized (i.e., length, width, diameter,circumference, area) to achieve a blood flow that will allow completionof a dialysis procedure within a target time period. FIG. 3A showsillustrative port 300. Port 300 may include one or more features of port107 (shown in FIG. 1) or port 202 (shown in FIG. 2). Port 300 may bejoined to a blood vessel via patch 237. Patch 237 may be constructedfrom Dacron, Gore-Tex, PTFE, fluoropolymer products or any othersuitable material. Patch 237 may include excess material. The excessmaterial may be “trimmed” by a surgeon or other practitioner allowingfor tailored positioning of patch 237. Patch 237 may be affixed to ablood vessel such as artery 101, vein 103 (shown in FIG. 1) or bloodvessel 243 (shown in FIG. 2). Patch 237 may be affixed to a blood vesselby anastomosis and arteriotomy or any other suitable technique. Theanastomosis may include an end-to-end angled anastomosis. Theanastomosis may include a side to end or side to side anastomosis.

Port 300 may include housing 311. Port 300 may include chamber 307. Port300 may include passageway 317. Port 300 may include sealing member 309.Sealing member 309 may be rigid.

Port 300 may include flexible sealing portion 301. Flexible sealingportion 301 may be constructed from Dacron, Gore-Tex, PTFE,fluoropolymer products or any other suitable material. Flexible sealingportion 301 may be affixed to a first end of sealing member 309.

A second end of sealing member 309 may be affixed to hinge 319.Injecting a medium into chamber 307 may expand chamber 307. Chamber 307may expand by rotating sealing member 309 through variable angle ρ.Pressure within chamber 307 may position sealing member 309 by rotationthrough angle ρ. Pressure within chamber 307 may position sealing member309 substantially parallel to patch 237. Expansion of chamber 307 mayposition flexible sealing portion 301 substantially perpendicular tosealing member 309.

When sealing member 309 is positioned substantially parallel to patch237, blood may be prevented from flowing between patch 237 and orifice305. Positioning sealing member 309 substantially perpendicular tosealing portion 301 may obstruct passageway 317. Positioning sealingportion 301 substantially perpendicular to sealing member 309 mayprevent a flow through orifice 305. Sealing portion 301 may prevent aflow between passageway 317 and a tubing connection joined to adapter315. The tubing connection may include any suitable tubing such astubing 111 (shown in FIG. 1) or tubing 204 (shown in FIG. 2).

Orifice 305 may be directly coupled to a reservoir, such as reservoir206 (shown in FIG. 2). Adapter 315 may be directly coupled to areservoir, such as reservoir 206 (shown in FIG. 2). Channel 303 may bedirectly coupled to a reservoir such as a reservoir 206. One or morecomponents of port 300 or port 202 (shown in FIG. 2) may be directlycoupled to one or more components a reservoir such as reservoir 206(shown in FIG. 2) or reservoir 109 (shown in FIG. 1).

Injecting a medium into chamber 307 may position sealing member 309substantially parallel to patch 237. In a preferred embodiment, themedium may be a liquid. The medium may be a gas or any suitable medium.The medium may be injected into chamber 307 via channel 303.

FIG. 3B shows illustrative port 302. Port 302 may include one or morefeatures of port 300 (shown in FIG. 3A), port 202 (shown in FIG. 2) orport 107 (shown in FIG. 1). Port 302 may include orifice 321. Orifice321 may allow blood travelling in blood vessel 323 to enter port 302.Orifice 321 may allow blood in port 302 to flow into blood vessel 323.Blood vessel 323 may be an artery. Blood vessel 323 may be a vein. Bloodvessel 323 may be any suitable lumen of a circulatory system.

Orifice 321 may be sealed by swing-arm 203 (shown in FIG. 2) or sealingmember 309 (shown in FIG. 3A). Sealing of orifice 321 may prevent bloodor any other medium from flowing through orifice 321. Orifice 321 may besealed following completion of a dialysis procedure.

Port 302 includes orifice 305 (also shown in FIG. 3A). Orifice 305 mayallow blood to flow between a tubing and passageway 321. The tubing mayinclude any suitable tubing such as tubing 111 (shown in FIG. 1) ortubing 204 (shown in FIG. 2). Orifice 305 may be sealed by sealingportion 301 (shown in FIG. 3A). Sealing orifice 305 may prevent a flowof blood through orifice 305. Orifice 305 may be sealed followingcompletion of a dialysis procedure. Port 302 may be configured to sealorifice 305 prior to sealing orifice 321.

FIG. 4 shows illustrative port components 400. Port components 400 mayinclude one or more features of port 300 (shown in FIG. 3A), port 302(shown in FIG. 3B), port 202 (shown in FIG. 2) or port 107 (shown inFIG. 1). Port components 400 include housing 415. Housing 415 may beaffixed to a blood vessel via patch 237. Housing 415 includes orifices413 and 419. Blood may flow from orifice 419 to orifice 413. Blood mayflow from orifice 413 to orifice 419. Blood may flow through passageway414. Orifices 413 and 419 may be sized to allow for an optimal rate ofblood flow.

For example, orifice 413 may be larger in area than orifice 419. Orifice413 may be sized proportionally to patch 237. Orifices 413 and 419 maybe sized to complete a dialysis procedure within a target time period.

Port components 400 may include sealing member 421. Sealing member 421may include one or more features of swing-arm 203 (shown in FIG. 2) orsealing member 309 (shown in FIG. 3A). Sealing member 421 may beconfigured to seal orifice 413. Sealing orifice 413 may prevent a flowof blood through orifice 413. Sealing member 421 may be rigid.

Sealing member 421 may include one or more tenons 403. Tenons 403 may beseated in mortise 401. Tenons 403 may rotate in mortise 401. Tenons 403and mortise 401 may form a flexible joint. The flexible joint mayinclude one or more features of hinge 319 (shown in FIG. 3A) or hinge233 (shown in FIG. 2).

Port components 400 include balloon 405. Balloon 405 may be inflated.Balloon 405 may be inflated by injecting a medium through orifices 407.Balloon 405 may be deflated. Balloon 405 may be deflated by extractingthe medium via orifices 407. Balloon 405 may include one or morefeatures of chamber 307 (shown in FIG. 3A) or chamber 203 (shown in FIG.2).

Balloon 405 may be configured to expand and/or contract about angle θ.When balloon 405 is deflated, balloon 405 may be configured to foldalong creases 409. Balloon 405 may be affixed to sealing member 421.Expansion and/or contraction of balloon 405 may position sealing member421 relative to orifice 413.

Balloon 405, when inflated, may position sealing member 421 over orifice413. Balloon 405 may apply pressure to sealing member 421 to create aleak-proof seal over orifice 413. When positioned over orifice 421,sealing member 421 may prevent blood flow through passageway 414.Balloon 405 may be inflated to a pre-determined pressure. Thepre-determined pressure may correspond to a position of sealing member421 relative to orifice 413.

Balloon 405 may include panel 423. Balloon 405 may include panel 425.Balloon 405 may seal orifice 419. Inflating balloon 405 may seal orifice419. Balloon 405 may include one or more features of sealing portion 301(shown in FIG. 3A). The pre-determined pressure may correspond to aposition of panels 423 and 425 relative to orifice 419. Thepre-determined pressure may correspond to panels 423 and 425 beingpositioned substantially parallel to orifice 419.

Housing 415 may include orifices 417. Orifices 417 may be aligned withorifices 407 of balloon 405. Inflating balloon 405 may include injectinga medium though orifices 417, through orifices 407 and into balloon 405.Deflating balloon 405 may include extracting the medium from balloon 405via orifices 407 and 417.

In some embodiments, a top of panel 425 may be affixed to housing 415below orifices 417. Housing roof 411 may form a top of balloon 405.Medium flowing through orifices 417 may “spill” into balloon 405expanding balloon 405.

Port components 400 include housing roof 411. Balloon 405 may be affixedto housing roof 411. Housing roof 411 may remain stationary relative tomovement of sealing member 421. Housing roof 411 may remain stationaryrelative to inflation/deflation of balloon 405. Deflating balloon 405may generate a negative pressure inside balloon 405. The negativepressure may move sealing member 421 relative to housing roof 411.Negative pressure inside balloon 405 may move sealing member 421relative to orifice 413.

Housing roof 411 may include biasing members (not shown). The biasingmembers may include elastic membranes, springs or any suitable biasingmember. The biasing members may include one or more feature of biasingmembers 221 (shown in FIG. 2). The biasing members may be positionedbetween housing roof 411 and sealing member 421. The biasing members maypenetrate balloon 405. The biasing members may be encapsulated withinballoon 405. The biasing members may bias sealing member 421 relative tohousing roof 411.

The bias may correspond to attraction between sealing member 421 andhousing roof 411. The bias may correspond to repulsion between sealingmember 421 and housing roof 411. The biasing members may pull sealingmember 421 away from orifice 413 during a deflation of balloon 405. Thebiasing members may pull sealing member 421 toward orifice 413 duringinflation of balloon 405.

FIG. 5A shows illustrative tubing 500. Tubing 500 may include one ormore features of tubing 204 (shown in FIG. 2) or tubing 111 (shown inFIG. 1). Tubing 500 may be affixed to a blood vessel via an angledbulbous anastomosis and arteriotomy. Via the angled bulbous anastomosisand arteriotomy, tubing 500 may be affixed a blood vessel such as anartery or vein without a port such as port 300 (shown in FIG. 3A), port202 (shown in FIG. 2) or port 107 (shown in FIG. 1). In a preferredembodiment, tubing 500 is coupled to a port such as port 300 (shown inFIG. 3A), port 202 (shown in FIG. 2) or port 107 (shown in FIG. 1)

Tubing 500 includes sheath 502. Tubing 500 includes baffle 505. Tubing500 includes lumen 501. Tubing 500 includes lumen 503. Baffle 505 mayseparate lumen 501 and lumen 503. Lumen 503 may transport a medium forinflating/deflating balloon 405 (shown in FIG. 4). Lumen 503 may carry amedium for increasing pressure in chamber 205 (shown in FIG. 2) orchamber 307 (shown in FIG. 3A). Lumen 503 may transport blood between ablood vessel and reservoir 213 (shown in FIG. 2). Lumen 501 may includeone or more features of lumen 503.

In a preferred embodiment, a blood transporting lumen of tubing 500 isoriented superiorly with respect to an outer body surface orintegumentary tissue. A superiorly oriented lumen may allow access tothe blood carrying lumen. Access may be needed to clear a thrombosis orother obstruction in the blood carrying lumen.

Baffle 505 may be configured to stretch. Baffle 505 may be configured tobend. Baffle 505 may be configured to obstruct lumen 501 and/or lumen503. Baffle 505 may impermeably obstruct lumen 501 or lumen 503. Forexample, a medium may be injected into lumen 501 via needle 227 (shownin FIG. 2). The medium may enter lumen 501 and fill chamber 307 (shownin FIG. 3A). The filling of chamber 307 may increase pressure on atleast a portion of sheath 502 and baffle 505. Baffle 505 may be elastic.

Sheath 502 may be inelastic relative to baffle 505. In response to theincreased pressure, baffle 505 may bulge into lumen 503. Baffle 505 maybulge and obstruct a flow through lumen 503. Pressure inside lumen 501may be increased until baffle 505 bulges and impermeably seals lumen503.

Baffle 505 may bend at different rates along a length of sheath 502.Different bending properties along the length of sheath 502 may resultin baffle 505 “pushing” blood or other medium in lumen 503 along thelength of sheath 502. For example, a first length of baffle 505 alongaxis Y may be configured to bulge when subject to a pressure of P1. Asecond length of baffle 505 along axis Y may be configured to bulge whenthe pressure corresponds to P2. P1 and P2 may be any suitable values ofpressure. In a preferred embodiment P2 is greater than P1. Baffle 505may be associated with any suitable pressure gradient along axis Y.

FIG. 5B shows a sectional view of an illustrative expansion of lumen 503and corresponding sealing of lumen 501. At point A, a diameter of lumen501 may be at a maximum. At point A, a diameter of lumen 503 may be at aminimum. When the diameter of lumen 501 is at a maximum, lumen 501 maybe configured to transport a target flow. The target flow may correspondto a flow of blood from a blood vessel to dialysis machine 115 (shown inFIG. 1).

At point B, a medium may be injected into lumen 503. Injection of themedium may increase pressure inside lumen 503. The increased pressureinside lumen 503 may result in baffle 505 bulging into lumen 501. Thebulging of baffle 505 into lumen 501 may obstruct a flow through lumen501. Baffle 505 may be configured to adjust a flow rate through lumen501.

At point C, continuous injection of the medium into lumen 503 has“stretched” baffle 505 across lumen 501 and against sheath 502. Thepressure of baffle 505 pressing against sheath 502 may impede a flowthrough lumen 501. The pressure of baffle 505 pressing against sheath502 may create an impermeable seal that prevents a flow through lumen501.

FIG. 5C shows illustrative tubing 504. Tubing 504 may include one ormore features of tubing 111 (shown in FIG. 1), tubing 204 (shown in FIG.2) or tubing 500 (shown in FIG. 5A). Tubing 504 may terminate in anangled bulbous anastomosis and arteriotomy. Via the angled bulbousanastomosis and arteriotomy, tubing 500 may be directly affixed a bloodvessel such as an artery or vein.

Tubing 504 includes sheath 510. Tubing 504 includes lumen 507. Lumen 507may be open at a first end of tubing 504. Lumen 507 may be closed at asecond end of tubing 504. Tubing 504 includes lumen 514. Tubing includesinner lining 511. Tubing 504 includes plug 509. Plug 509 may berotatably connected to inner lining 511. Plug 509 may be connected toinner lining 51 using Dacron, Gore-Tex, PTFE, fluoropolymer products orany suitable material. Inner lining 511 and plug 509 may rotate, withrespect to each other, about angle α.

At point A, angle α may be approximately 180°. At point A, a diameter oflumen 514 may be at a maximum. When the diameter of lumen 514 is at amaximum, lumen 514 may be configured to transport a target flow. Thetarget flow may correspond to a flow of blood from or to a blood vessel.

At point B, a medium may be injected into lumen 507. Injection of themedium into lumen 507 may cause adjustment of angle α between innerlining 511 and plug 509. Injection of the medium into lumen 507 maydecrease angle α. A decrease in angle α may correspond to an increase ina diameter of lumen 507. A decrease in angle α may correspond to adecrease in a diameter of lumen 514. A decrease in the diameter of lumen514 may obstruct a flow through lumen 514.

At point C, angle α may be approximately 90°. At point C, plug 509 mayblock any flow into or through lumen 514. At point C, lumen 507 may befull of the injected medium. The injected medium may generate pressureinside lumen 507. The pressure may maintain a position of plug 509 withrespect to lumen 514. The pressure may maintain a value of angle α. Thepressure may maintain a value of angle α at approximately 90°.

The medium may be injected into lumen 514 using needle 227 (shown inFIG. 2). Self-sealing membrane 225 (shown in FIG. 2) may maintain theinjected medium and corresponding pressure inside lumen 507.

FIG. 5D shows illustrative views A-C of tubing 504. Each of views A-Ccorresponds to a change in angle α and corresponding position of plug509 within lumen 514.

At point A, angle α is approximately 180°. At point A, a diameter oflumen 514 is at a maximum. At point B, angle α has been decreased. Thedecrease in angle α corresponds to a decrease in the diameter of lumen514. The decrease in angle α corresponds to an increase in a diameter oflumen 507. Injecting a medium into lumen 507 may result in plug 509extending into lumen 514. Injecting a medium into lumen 507 may resultin plug 509 obstruction at least a portion of lumen 514. Rotation ofplug 509 relative to inner lining 511 may correspond to a decrease inangle α.

At point C, plug 509 is positioned to prevent blood or any other fluidfrom entering lumen 514. At point C, a diameter of lumen 507 is at amaximum. Extracting the medium from lumen 507 may increase angle α, andallow a flow to enter lumen 514.

FIG. 5E shows illustrative views 506A and 506B of a portion of tubing500 taken along lines 1-1 (shown in FIG. 5A). Tubing 500 (shown in FIG.5A), tubing 204 (shown in FIG. 2) or tubing 111 (shown in FIG. 1) mayinclude one or more features of illustrative view 506.

Illustrative view 506A shows sheath 508. Illustrative view 506A showsbaffle 515. Illustrative view 506A shows lumen 513 and lumen 517. Atleast a portion of lumen 517 may be lined with a flexible material suchas Dacron, Gore-Tex, PTFE, fluoropolymer products or any suitablematerial. Baffle 515 may be the portion of lumen 517 lined with theflexible material. When lumen 513 is filled with a medium, baffle 515may expand or “bulge” into lumen 517. Expansion of baffle 515 into lumen517 may decrease a diameter of lumen 517 and obstruct a flow throughlumen 517. Baffle 515 may expand through lumen 517 and press against arigid portion of sheath 508. The pressure of baffle 515 against sheath508 may impermeably seal lumen 517.

In some embodiments, blood may travel through lumen 517. Lumen 517 maybe oriented superiorly with respect to an outer body surface orintegumentary tissue. A superiorly oriented lumen may allow access tothe blood carrying lumen. Access may be needed to clear a thrombosis orother obstruction in the blood carrying lumen.

In some embodiments, lumen 517 may be filled with a medium. Baffle 515may expand or “bulge” into lumen 513. Expansion of baffle 515 into lumen513 may decrease a diameter of lumen 513 and obstruct a flow throughlumen 513. Baffle 515 may expand through lumen 513 and press against arigid portion of sheath 508. The pressure of baffle 515 against sheath508 may impermeably seal lumen 513.

Illustrative views 506A and 506B show that sheath 508, lumen 517 andlumen 513 may include flexible material, rigid material or a combinationof both rigid and flexible material. Rigid material may includeplastics. The flexible material may include Dacron, Gore-Tex, PTFE,fluoropolymer products and any material suitable for implantation in ahuman body.

FIG. 5F shows illustrative views 572A and 572B. Illustrative view 572Ais taken along lines 2-2 (shown in FIG. 5C). Illustrative view 572B istaken along lines 3-3 (shown in FIG. 5C).

Illustrative view 572A shows sheath 519. Illustrative view 572A showsridge 521. Ridge 521 may be configured to provide a “catch” for a plug,such as plug 509 (shown in FIG. 5C). When angle α (shown in FIG. 5C) isapproximately 90°, plug 509 may be pressed against ridge 521. Pressingplug 509 against ridge 521 may create a seal that prevents a flow fromentering lumen 523. The flow may correspond to blood circulating in ablood vessel.

Illustrative view 572B shows an exemplary circular shape of ridge 521.Illustrative view 572B shows that ridge 521 may form a lining betweensheath 519 and lumen 523. A plug such as plug 509 (shown in FIG. 5C) maybe configured to close lumen 523 by pressing on ridge 521. Plug 509 mayhave a circular shape.

Plug 509 may have a diameter that is larger than the diameter of ridge521 and smaller than a diameter of sheath 519. Plug 509 may be squareshaped, triangle shaped or have any suitable shape.

FIG. 5G shows illustrative tubing arrangements and therapeutictechniques 516, 518, 520, 522, 524A, 524B, 526, 528A and 528B.

Tubing arrangement 516 shows an illustrative anastomosis andarteriotomy. Tubing arrangement 516 shows lumen 537 and lumen 535.Arrangement 516 shows lumen 535 in a collapsed state and lumen 537 in anopen state. Lumens 535 and 537 may be affixed to patch 531. During ananastomosis and arteriotomy/venotomy patch 531 may be sutured intosurgical incision 533 in blood vessel 532. Expansion of lumen 535 mayseal lumen 537, and prevent blood from flowing out of blood vessel 532into lumen 537. Contraction of lumen 535 may allow blood to flow out ofblood vessel 532 into lumen 537. Blood entering lumen 537 from bloodvessel 532 may be transferred via lumen 537 to dialysis machine 115(shown in FIG. 1). Blood filtered by dialysis machine 115 may betransferred to blood vessel 532 via lumen 537.

Arrangement 518 shows an illustrative end-to-end “angled” anastomosis.Arrangement 518 shows lumen 541 and lumen 543. Lumens 541 and 543 may beaffixed to graft 539. Graft 539 may be sutured to blood vessel 532.Graft 539 may be sutured to blood vessel 532 at “angled” seam 538. Lumen543 may include one or more feature of lumen 537. Lumen 541 may includeone or more features of lumen 535.

Arrangement 520 shows an illustrative end-to-end “straight” anastomosis.Arrangement 520 shows lumen 547 and lumen 549. Lumens 547 and 549 may beaffixed to graft 545. Graft 539 may be sutured to blood vessel 532.Graft 545 may be sutured to blood vessel 532 at “straight” seam 546.Lumen 547 may include one or more features of lumen 535. Lumen 549 mayinclude one or more feature of lumen 537.

Arrangement 522 shows an illustrative angled “bulbous” anastomosis andarteriotomy. Arrangement 522 shows lumen 553 and lumen 555. Lumens 553and 555 may be affixed to patch 551. Patch 551 may be sutured to a bloodvessel such as blood vessel 532. Lumen 553 may include one or morefeatures of lumen 535. Lumen 555 may include one or more features oflumen 537.

Arrangement 524A shows an illustrative therapeutic scenario. Arrangement524A shows that tubing 559 may be angled with respect to patch 557.Tubing 559 may include one or more or more lumens, such as lumen 535and/or lumen 537. When tubing 563 is angled with respect to patch 561,angle ω may be greater than 90°. Tubing 559 may include one or morefeatures of tubing 111 (shown in FIG. 1), tubing 204 (shown in FIG. 2)tubing 500 (shown in FIG. 5A) or tubing 504 (shown in FIG. 5C).

Arrangement 524B shows another illustrative therapeutic scenario.Arrangement 524B shows that tubing 563 may be substantiallyperpendicular with respect to patch 561. When tubing 563 issubstantially perpendicular to patch 561, angle ω may be approximately90°. Tubing 563 may include one or more or more lumens, such as lumen535 and/or lumen 537. Tubing 559 may include one or more features oftubing 111 (shown in FIG. 1), tubing 204 (shown in FIG. 2) tubing 500(shown in FIG. 5A) and tubing 504 (shown in FIG. 5C).

An angle ω greater than 90° may maintain laminar blood flow within bloodvessel 532. An angle ω greater than 90° may reduce turbulent blood flowwithin blood vessel 532.

Arrangement 526 shows an illustrative therapeutic scenario. Arrangement526 shows tubing 573. Tubing 573 may include one or more features oftubing 500 (shown in FIG. 5A), tubing 504 (shown in FIG. 5C), tubing 204(shown in FIG. 2) or tubing 111 (shown in FIG. 1).

Tubing 573 includes lumen 571, lumen 575, plug 569 and ridge 565. Anexpansion of lumen 575 may rotate plug 569 about angle A. Rotation ofplug 569 about angle A may press plug 569 against ridge 565. Pressingplug 569 against ridge 565 may prevent blood from flowing through lumen571.

Lumen 575 may be expanded by injecting a medium into lumen 575. Themedium may be maintained inside lumen 575 by a reservoir. The reservoirmay be any suitable reservoir such as reservoir 231 (shown in FIG. 2) orreservoir 109 (shown in FIG. 1). A pressure of plug 569 against ridge565 may be maintained by a reservoir, such as reservoir 231.

Arrangement 528A shows an illustrative therapeutic scenario. Arrangement528A shows tubing 577 affixed to “flat” patch 581. Flat patch 581 may besutured to a blood vessel such as blood vessels 103 or 101 (shown inFIG. 1). After attachment to the blood vessel, tubing 577 may act asconduit to transfer blood to/from the blood vessel. Tubing 577 mayinclude a plug such as plug 569 or a baffle such as baffle 515 (shown inFIG. 5E). The plug or baffle may be configured to seal tubing 577 andprevent a flow through tubing 577.

Arrangement 528B shows another illustrative therapeutic scenario.Arrangement 528B shows tubing 579 affixed to “curved” patch 583. Curvedpatch 583 may be sutured to a blood vessel such as blood vessels 103 or101 (shown in FIG. 1). After attachment to the blood vessel, tubing 577may act as conduit to transfer blood to/from the blood vessel. Tubing579 may include a plug such as plug 569 or a baffle such as baffle 515(shown in FIG. 5E). The plug or baffle may be configured to seal tubing577 and prevent a flow through tubing 579.

FIG. 6A shows illustrative apparatus 600. Apparatus 600 includesreservoir 601. Reservoir 601 may include one or more features ofreservoir 223, reservoir 231 (both shown in FIG. 2) or reservoir 109(shown in FIG. 1).

Reservoir 601 includes chamber 613. Reservoir 601 includes self-sealingmembrane 615. Translation of platform 611 may expand or contract chamber613. Platform 611 may be biased within reservoir 601 by springs 619.Platform 611 may be biased relative to self-sealing membrane 615 bysprings 619. Platform 611 may be biased using any suitable pressureexerting member. Platform 611 may be biased to exert pressure onself-sealing membrane 615.

Needle 617 may penetrate self-sealing membrane 615. Needle 617 may be influid connection with feeds 113 (shown in FIG. 1). Inserting needle 617into chamber 613 may separate platform 611 from self-sealing membrane615. Pressure applied to needle 617 may condense springs 619 andtranslate platform 611. Translation of platform 611 away fromself-sealing membrane 615 may expand chamber 613. Expanding chamber 613may allow blood to flow from lumen 603 or 605 into chamber 613. Adapter635 may provide a leak-proof seal between chamber 613 and lumen 603 orlumen 605.

Needle 617 may extract blood from chamber 613. Blood extracted fromchamber 613 may be transferred to dialysis machine 115 (shown in FIG.1). Blood extracted from chamber 613 may be filtered by dialysis machine115. Blood filtered by dialysis machine 115 may be reintroduced intocirculation by injecting the filtered blood into chamber 613.

Chamber 613 may include walls 604. Walls 604 may be flexible. Walls 604may be constructed from Dacron, Gore-Tex, PTFE, fluoropolymer productsor any other suitable material. Walls 604 may allow for expansion and/orcontraction of chamber 613. Walls 604 may prevent blood from leaking outof chamber 613.

When needle 617 is removed from self-sealing membrane 615, springs 619may exert pressure on platform 615. Springs 619 may “push” platform 615toward self-sealing membrane 615. Movement of platform 615 towardself-sealing membrane may purge excess fluid from chamber 213. After atransfer of blood through chamber 613, chamber 613, tubing 607 andpassageway 207 (shown in FIG. 2) may be purged of residual blood bymovement of platform 611.

FIG. 6B shows illustrative scenario 602. In scenario 602, platform 611is pressed against self-sealing membrane 615. Biasing members 619 mayapply pressure to platform 611. The pressure applied by biasing members619 may cause platform 619 to translate. The pressure applied by biasingmembers 619 may cause platform 619 to translate and contract chamber613. The pressure applied by biasing members 619 may press platform 611against self-sealing membrane 615.

Translation of platform 611 and a corresponding contraction of chamber613 may expel medium present in chamber 613. The expulsion of mediumpresent in chamber 613 may force the medium through tubing 607 andthrough passageway 207. The expulsion of the medium from chamber 613 maycleanse tubing 607 and/or passageway 207.

For example, a first end to tubing 607 may be joined to adapter 635. Asecond end of tubing 607 may be joined to housing 201 via adapter 239(shown in FIG. 2). A saline solution may be introduced into chamber 613and tubing 607. The saline solution may flush out any blood present inchamber 613, tubing 607 or housing 201.

After introducing the saline solution, needle 617 may be removed fromchamber 613. Removal of needle 617 may allow platform 611 to translatetoward self-sealing membrane 615. Translation of platform 611 andcorresponding contraction of chamber 613 may “squeeze” the salinesolution out of chamber 613, through tubing 607 and through passageway207, thereby purging residual blood and/or saline present in chamber613, tubing 607 and/or passageway 207 (shown in FIG. 2). The salinesolution may be a heparinized solution designed to prevent bloodclotting within chamber 613, tubing 607 and/or passageway 207.

When platform 611 presses against self-sealing membrane 615, walls 604may fold into cutouts 608. When needle 617 pushes platform 611 away fromself-sealing member, walls 604 may un-fold and form sides of chamber613.

FIG. 7 shows illustrative apparatus 700, 702, 704A and 704B.

Apparatus 700 includes reservoir 701. Reservoir 701 may include one ormore features of reservoir 223, reservoir 231 (shown in FIG. 2) orreservoir 109 (shown in FIG. 1). Apparatus 700 includes tubing 737.Tubing 737 may include one or more features of tubing 500 (shown in FIG.5A), tubing 504 (shown in FIG. 5C), tubing 204 (shown in FIG. 2) ortubing 111 (shown in FIG. 1). A first end of tubing 737 may be joined toreservoir 701. A second end of tubing 737 may be joined to a port suchas port 400 (shown in FIG. 4), port 300 (shown in FIG. 3A), port 302(shown in FIG. 3B), port 202 (shown in FIG. 2) or port 107 (shown inFIG. 1).

Reservoir 701 includes self-sealing membranes 721 and 725. A needle maypenetrate self-sealing membrane 721 and inject a medium into chamber710. The injected medium may enter chamber 705 via channel 703 andorifice 713. Chamber 705 may be defined, at least in part, by floor 715.The injected medium may push platform 731 away from floor 715 and closerto self-sealing membrane 725.

Reservoir 701 may include biasing members 712 between platform 731 andfloor 715. The biasing members may include a spring, elastic membrane orany other suitable biasing members. In response to reducing pressureapplied to platform 731, platform 731 may translate towards membrane725. A translation of platform 731 toward membrane 725 may collapselumen 723. A collapsed lumen 723 may be expanded by inserted a needle(not shown) through membrane 725. The needle may apply pressureovercoming a biasing force of biasing members 712. Biasing members 712may be insulated and/or sealed from a medium present in chamber 705.

Injecting the medium into chamber 710 may result in platform 731translating towards self-sealing membrane 725. The translation ofplatform 731 may force a cleansing agent present in chamber 723 intolumen 733 and through passageway 207 (shown in FIG. 2). The flow of thecleansing agent through passageway 207 may sanitize lumen 733 and/orpassageway 207.

Chamber 710 may be in fluid contact with lumen 735. The injected mediummay flow through chamber 710 into lumen 735. Adapter 729 may fluidlyjoin chamber 710 and lumen 735. Injection of the medium into chamber 710may expand lumen 205 and rotate swing-arm 203 about hinge 233 (shown inFIG. 2).

In response to the injection of medium into chamber 710, platform 731may be configured to translate and contract chamber 723. Chamber 723 maybe contracted prior to the fluid exerting sufficient pressure to expandlumen 735. In response to the injection of medium into chamber 703,lumen 735 may expand, thereby sealing lumen 733. Lumen may be sealedprior the injected fluid exerting sufficient pressure to expand lumen205 (shown in FIG. 2) and/or seal orifice 413 (shown in FIG. 4).

Apparatus 704 shows an illustrative component. Apparatus 704 included ina reservoir, such as reservoir 701, reservoir 223, reservoir 231 (shownin FIG. 2) or reservoir 109 (shown in FIG. 1). Apparatus 704 includesmembrane 739. Membrane 739 may be a self-sealing membrane. Apparatus 704may include platform 743. Platform 743 may be rigid.

Platform 743 may be configured to translate along axis X. A flow offluid into chamber 705 may cause platform 743 to translate towardsmembrane 739. Translation of platform 743 toward membrane 739 may foldwalls 707. Walls 707 may be biased to fold out of chamber 741.Translation of platform 743 toward membrane 739 may extend walls 709.Translation of platform 743 toward membrane 739 may expand chamber 705.

An extraction of fluid from chamber 705 may cause platform 743 totranslate toward floor 745. An extraction of fluid from chamber 705 maycreate a negative pressure. The negative pressure may pull platform 743toward floor 745.

Platform 743 may be biased along axis X. Platform 743 may be biased byone or more biasing members, such as biasing members 221 (shown in FIG.2).

Translation of platform 743 toward floor 745 may fold walls 709. Walls709 may be biased to fold out of chamber 705. Translation of platform743 toward floor 745 may extend walls 707. Translation of platform 743toward floor 745 may expand chamber 741.

Apparatus 704A shows an inferior view of reservoir 701. The inferiorview shows an outer housing 711 of channel 703. The inferior view showsa circular area swept out by walls 715. In broken line, the inferiorview shows a circular area swept out by orifice 713. The inferior viewshows an underside of chamber 710. Channel 703 may terminate at adapter729. The inferior view shows an underside of adapter 729. Channel 703may be joined to tubing 737 using adapter 729.

Apparatus 704B shows superior view of reservoir 701. The superior viewshows self-sealing membrane 725. Self-sealing membrane 725 may capchamber 723. The superior view shows self-sealing membrane 721.Self-sealing membrane 721 may cap chamber 710. The superior view alsoshows a top of adapter 727. Adapter 727 may join chamber 723 and tubing737.

FIG. 8 shows illustrative apparatus 800A, 800B, 800C and exemplarytherapeutic scenario 800D.

Apparatus 800A may be used to join blood vessel 802 and blood vessel804. Apparatus 800A may provide a system that allows blood to beextracted from one of blood vessels 802 or 804 and returned to one ofblood vessels 802 or 804. Blood extracted from blood vessel 802 or 804may be processed before being reintroduced into circulation. Theextracted blood may be dialysized before being returned to circulation.Apparatus 800A may provide a system that allows for blood to selectivelyflow between blood vessel 802 and blood vessel 804. Apparatus 800A mayprovide a system that prevents blood from continuously flowing betweenblood vessel 802 and blood vessel 804. For example, when blood is notbeing processed, blood may not flow through port 810, port 803, tubing805 or reservoir 806.

Apparatus 800A includes port 803. Port 803 may include one or morefeatures of port 202 (shown in FIG. 2), ports 300 and 302 (shown in FIG.3) and port 400 (shown in FIG. 4). Apparatus 800A includes port 810.Port 810 may include one or more features of port 202 (shown in FIG. 2),ports 300 and 302 (shown in FIG. 3) and port 400 (shown in FIG. 4).

Port 803 may be affixed to blood vessel 802. Port 803 may be affixed toblood vessel 804. Port 803 may be affixed to blood vessel 802 or 804using any suitable technique such as the techniques shown in FIG. 5G.

Port 803 may be joined to tubing 805. Tubing 805 may include one or morefeatures of tubing 111 (shown in FIG. 1), tubing 204 (shown in FIG. 2)and any tubings shown in FIGS. 5A-5G. In some embodiments (not shown),tubing 805 may be joined to blood vessel 802 or 804 without port 803.

Tubing 805 may be joined to blood vessel 802 or 804 using any suitabletechnique such as the exemplary techniques shown in FIG. 5G.

Tubing 805 may join port 803 to reservoir 806. Tubing 805 may be joinedto port 803 using adapters 239 or 241 (shown in FIG. 2), adapters 315 or313 (shown in FIG. 3A), a “Christmas tree” type adapter, threaded screwor any suitable adapter. Tubing 805 may be fused to port 803.

Apparatus 800B and 800C show illustrative components of reservoir 806.Apparatus 800B includes chambers 808, 809 and 811. Chambers 809 and 811may each include one or more features of reservoir 601. For example,each of chambers 809 and 811 may be biased with respect to chamber 808by biasing members such as biasing members 619.

Chamber 808 may be stacked above chambers 809 and 811. In someembodiments (not shown), chambers 809 and 811 may be stacked abovechamber 808. Chamber 808 may be capped with membrane 807 (shown in800A). Membrane 807 may be a self-sealing membrane. Chambers 809 and 811may be separated by dividing wall 813. Dividing wall 813 may be animpermeable barrier. Apparatus 800C shows that chamber 808 may beseparated from chambers 809 and 811 by membrane 819. Membrane 819 may bea self-sealing membrane.

Tubing 805 may be coupled to chambers 808 and 811 via adapters 831 and835. Tubing 805 may be coupled to chambers 808 and 809 via adapters 825and 823.

Extracting a medium present in chamber 808 may unseal a swing-arm withinport 803 (shown in 800A) and/or port 810. Extracting a medium present inchamber 808 may unseal a lumen in tubing 805. Unsealing the lumen withintubing 805 and the swing-arm within port 803 may allow blood to flowbetween port 803 and chamber 811. Unsealing the lumen within tubing 805and the swing-arm within port 810 may allow blood to flow between port810 and chamber 809.

A needle (not shown) may penetrate membranes 807 and 819 and extractblood from chamber 811. By accessing chamber 811, blood may be extractedfrom blood vessel 804 (shown in 800A). Blood vessel 804 may be anartery. A needle (not shown) may penetrate membranes 807 and 819 andinject filtered blood into chamber 809. By accessing chamber 809, bloodmay be injected into blood vessel 802 (shown in 800A). Blood injectedinto chamber 809 may flow through tubing 805, though port 810 and intoblood vessel 802. Blood vessel 802 may be a vein. Blood vessel 802 maybe a vein.

Blood extracted from chamber 811 may be filtered by dialysis machine 115and returned to chamber 809. After a completion of a dialysis procedure,a medium, such as heparinized saline, may be injected into chamber 811and/or chamber 809. Injection of the medium may flush any residual bloodwithin chamber 811, chamber 809, tubing 805, port 810 and/or port 803.

A medium may be injected into chamber 808. Injecting the medium intochamber 808 may insulate tubing 805 and port 803 from blood flow inblood vessel 804. Tubing 805 may be constructing with varying degrees ofbending resistance so that a first portion of tubing 805 closer tochamber 811 is sealed prior to a second portion of tubing 805 closer toport 803. Tubing 805 may be sealed prior to sealing port 803.

In some embodiments, a cleansing solution, such as heparinized salinemay be injected into chamber 811. The heparinized saline may clear bloodpresent in chamber 811, tubing 805 and/or port 803. Following injectionof the heparinized saline, a medium may be injected into lumen 808sealing the transport system.

Injecting the medium into chamber 808 may seal tubing 805 and port 810from blood flow within blood vessel 802. Tubing 805 may be constructingwith varying degrees of bending resistance so that a first portion oftubing 805 closer to chamber 811 is sealed prior to a second portion oftubing 805 closer to port 810. Tubing 805 may be sealed prior to sealingport 810.

A needle inserted into reservoir 806 may include a pressure gauge (notshown). When the pressure gauge registers a threshold pressure, tubing805, port 803 and port 810 may all be sealed from blood flow in vessels804 and 802. Membrane 807 and membrane 819 may maintain the thresholdpressure within chamber 808 after needle 816 is withdrawn.

In some embodiments, reservoirs 808, 809 and 811 may be positionedadjacent to one another in a plane. For example, reservoirs 808, 809 and811 may form a “three leaf clover” shape. Each of reservoirs 808, 809and 811 may be a different shape. For example, reservoir 808 may have acircular shape. Reservoir 809 may have a square shape. Reservoir 811 mayhave a triangular shape. The different shapes may allow a practitioneraccessing the reservoirs to identify each reservoir by feeling orpalpitating each reservoir.

Scenario 800D shows an exemplary therapeutic scenario utilizing a“stacked” reservoir. The stacked reservoir may include one or morefeatures of reservoir 806 (shown in 800A). In scenario 800D, doublelumen needle 816 is inserted into chamber 837 by penetrating membranes829 and 833. Membrane 829 may include one or more features of membrane807 (shown in 800C). Membrane 833 may include one or more features ofmembrane 819 (shown in 800C). Lumen 817 may only penetrate membrane 829.Lumen 815 may penetrate both membrane 829 and 833. Lumen 817 may extracta medium from within chamber 839.

Extracting the medium from chamber 839 may unseal a swing-arm within aport such as port 803 and/or port 810 (shown in 800A). The swing-arm mayinclude one or more features of swing-arm 203 (shown in FIG. 2),swing-arm 309 (shown in FIG. 3) or swing-arm 421 (shown in FIG. 4). Forexample, port 803 may be coupled to chamber 839 via a tubing connectionsuch as tubing 805 (shown in 800A). Unsealing the swing-arm may allowblood to flow from blood vessel 804 (shown in 800A) into port 803. Theswing-arm may seal an orifice (not shown) between blood vessel 804 andhousing 803. The orifice may include one or more features of orifice 321(shown in FIG. 3) or orifice 413 (shown in FIG. 4).

Extracting the medium from chamber 839 may unseal a lumen (not shown)within the tubing coupled to chamber 839. For example, tubing 805 may becoupled to chamber 839, and a lumen within tubing 805 may include one ormore features of lumen 211 (shown in FIG. 2), lumen 501 (shown in FIG.5A) or lumen 514 (shown in FIG. 5C). Unsealing the lumen may allow bloodto flow into chamber 837. Blood flowing into chamber 837 may beextracted via lumen 815 of needle 816. Blood extracted via lumen 815 maybe transferred to dialysis machine 115 using feeds 113 (shown in FIG.1). Blood extracted via lumen 815 from chamber 837 may be filtered bydialysis machine 115 and returned to chamber 809 (shown in 800A) or areservoir such as reservoir 223 (shown in FIG. 2).

FIG. 9 shows illustrative process 900. Process 900 includes, at step901, opening a first system. The first system may include a first port.The first port may include one or more features of port 803 (shown inFIG. 8), port 300 (shown in FIG. 3A), port 202 (shown in FIG. 2) or port107 (shown in FIG. 1). The first system may include a first tubing. Thefirst tubing may one or more features of tubing 805 (shown in FIG. 8),tubing 500 (shown in FIG. 5A), tubing 504 (shown in FIG. 5C), tubing 204(shown in FIG. 2) or tubing 111 (shown in FIG. 1). The first system mayinclude a first subcutaneous reservoir. The first reservoir may includeone or more features of reservoir 806 (shown in FIG. 8), reservoir 231(shown in FIG. 2) or reservoir 109 (shown in FIG. 1).

Opening the first system may allow blood from a first blood vessel toflow through the first system. At step 903, blood flows through thefirst port, the first tubing and through the first subcutaneousreservoir. At step 905, blood flowing through the first system isdirected to a dialysis machine. The dialysis machine filters the blood.

At step 907, a second system is opened. The second system may includeone or more features of the first systems. For example the second systemmay include a second port, a second tubing, and a second subcutaneousreservoir. At step, 909, filtered blood is transferred from the dialysismachine to the second subcutaneous reservoir. At step 911, the filteredblood flows through the second subcutaneous reservoir, through thesecond tubing, and through the second port. The second port returns thefiltered blood circulation via a second blood vessel.

FIG. 10 shows illustrative process 1000. Process 1000 includes, at step1001, flushing a transport system. The transport system may include oneor more features of apparatus 800A (shown in FIG. 8) or apparatus 200(shown in FIG. 2). For example the transport system may include a firstreservoir such as reservoir 206 (shown in FIG. 2), a first lumen such aslumen 501 (shown in FIG. 5) and a port such as port 400 (shown in FIG.4). The first lumen may be coupled to the first reservoir. The flushingmay include, using a syringe, injecting a cleansing medium into a firstreservoir.

At step 1003, the cleansing medium travels through the first reservoir,the first lumen and the port. At step 1005, a needle is removed from thefirst reservoir. Removing the needle releases a pressure exerting memberin the first reservoir. For example, the pressure exerting member maycorrespond to spring 221 (shown in FIG. 2). At step 1007, the pressureexerting member exerts pressure on a chamber of the first reservoir andcollapses the chamber. For example, the chamber may correspond tochamber 213 (shown in FIG. 2), chamber 723 (shown in FIG. 7) or chamber809 (shown in FIG. 8). Collapsing the chamber pushes any excesscleansing medium out of the chamber into the first lumen.

At step 1009, a medium is injected into a second reservoir of thetransport system. The second reservoir may include one or more featuresof reservoir 231 (shown in FIG. 2), reservoir 701 (shown in FIG. 7) orreservoir 806 (shown in FIG. 8).

At step 1011, the medium travels through the second reservoir andthrough a second lumen. The second lumen may be coupled to the secondreservoir. As the medium travels through the second lumen, the secondlumen may expand progressively sealing the first lumen. For example, thesecond lumen may correspond to lumen 735 and the first lumen maycorrespond to lumen 733 (shown in FIG. 7).

Expansion of the second lumen may progressively seal the first lumenalong a length of the second lumen. The second lumen may be configuredto seal the first lumen beginning at a point the first lumen is coupledto the first reservoir and ending at a point the first lumen is coupledto the port. Progressively sealing of the first lumen pushes any excessmedium in first lumen into the port.

At step 1013, the medium injected into the second reservoir flows fromthe second lumen into a chamber of the port. The flow of medium into theport exerts pressure on a swing-arm of the port. The swing-arm mayinclude one or more features of swing-arm 203 (shown in FIG. 2), sealingmember 309 (shown in FIG. 3A) or sealing member 421 (shown in FIG. 4).

In response to the pressure exerted on the swing-arm, the swing-armrotates, positioning a plug over an aperture between the port and thefirst lumen. Rotation of the swing-arm pushes any excess medium out ofthe port into a blood vessel. At step 1017, in response continued flowof medium into the chamber and corresponding pressure exerted on theswing-arm, the swing-arm continues rotating, sealing an aperture betweenthe port and the blood vessel. The aperture may include one or morefeatures of orifice 419 (shown in FIG. 4) or orifice 305 (shown in FIG.3A) orifice.

At step 1019, a threshold pressure is monitored at the point ofinjection into the second reservoir. In response to detection of thethreshold pressure, the needle is withdrawn from the second reservoir.The threshold pressure may correspond to a completion of the sealingprocess. A self-sealing membrane may prevent a change in pressure afterwithdrawing the needle.

FIG. 11 shows illustrative apparatus 1100. Apparatus 1100 includestubing 1101. Apparatus 1100 includes clamp 1102. Clamp 1102 includesfirst rotatable arm 1103 and second rotatable arm 1105. First rotatablearm 1103 is affixed to tubing 1102 via hinge 1115. Second rotatable arm1105 is affixed to tubing 1101 via hinge 1113.

Hinges 1113 and 1115 may be aligned over pivot 1117. Pivot 1117 mayprotrude from tubing 1101. Hinges 1113 and 1115 may be configured torotate about pivot 1117. Clamp 1102 may be affixed to tubing 1101 aftertubing 1101 is anastomized to blood vessel 1109. Hinges 1113 and 1115may be fitted over a pivot 1117 after tubing 1101 is anastomized toblood vessel 1109. In some embodiments, clamp 1102 may be manufacturedas part of tubing 1101.

Clamp 1102 includes O-ring 1107. O-ring 1107 may bias rotatable arms1103 and 1105 to compress flexible tubing portion 1111. FIG. 11 showsclamp 1102 in a closed position. O-ring 1107 may maintain clamp 1102 inthe closed position. In the closed position, clamp 1102 compressesflexible portion 1111 of tubing 1101.

When clamp 1102 compresses flexible portion 1111, tubing 1101 isinsulated from blood or any other medium flowing through vessel 1109.When clamp 1102 compresses flexible portion 1111, fluid present intubing 1101 is insulated from vessel 1109. When clamp 1102 compressesflexible portion 1111 of tubing 1101, fluid flowing through vessel 1109may flow across an anastomization site unimpeded by any portion oftubing 1101.

FIG. 12 shows illustrative apparatus 1200. Apparatus 1200 includestubing 1201. Tubing 1201 may be anastomized to conduit 1213. Conduit1203 may be any fluid carrying medium such as an artery or vein.Apparatus 1200 includes clamp 1202. Clamp 1202 may include one or morefeatures of clamp 1102 (shown in FIG. 11).

Clamp 1202 includes rotatable arms 1203 and 1205. Hinges 1211 mayrotatably fix rotatable arm 1203 to tubing 1201. Hinges 1209 mayrotatably fix rotatable arm 1205 to tubing 1201. Rotatable hinges 1211and 1209 may rotate about pivot 1215. Some embodiments may not includehinges. For example, rotatable arms 1203 and 1205 may be clipped orotherwise affixed to tubing 1201. A bending resistance of rotatable arms1203 and 1205 may provide flexibility for clamp 1202 to expand andcontract.

Clamp 1202 includes O-ring positions 1207. Each of O-ring positions 1207may be configured to position an O-ring around clamp 1202. An O-ringposition may be selected based on a property of the conduit, tubing,anastomosis, clamp or any suitable requirement. In some embodiments, theclamp may include one pre-determined O-ring position.

FIG. 12 shows clamp 1202 in an open position. In the open position,rotatable arms 1203 and 1205 are separated by distance D. Opening clamp1202 may pivot rotatable arms 1203 and 1205 about pivot 1215. An amountof force needed to open clamp 1202 may depend on a seating of O-ring(s)within one or more of O-ring positions 1207.

Opening clamp 1202 a distance D may allow fluid flowing thorough conduit1213 to enter tubing 1201.

FIG. 13A shows illustrative apparatus 1300. Apparatus 1300 showsapparatus 1200 without rotatable arm 1205 exposing balloon 1307, end cap1309, shoulder 1310 and tubing section 1311.

Balloon 1307 may encircle tubing section 1311. Tubing section 1311 mayextend concentrically though tubing section 1201. Tubing section 1311may include a compressible segment. Tubing section 1311 may include anon-compressible segment. Balloon 1307 may completely or partiallyencircle the non-compressible segment of tubing 1310. Balloon 1307 maybe in fluid communication with fluid carried in tubing 1201. The fluidflowing through tubing 1201 may be used to inflate balloon 1307. End cap1309 may prevent the fluid from leaking out of balloon 1307 and tubing1201.

Inflating balloon 1307 may rotate rotatable arm 1203 and 1205 (shown inFIG. 12) opening clamp 1202 (shown in FIG. 12). Balloon 1307 may bedeflated by allowing fluid to exit balloon 1307 through tubing 1201.Deflating balloon 1307 may allow clamp 1202 to compress tubing section1311. Shoulder 1310 may compress a portion of tubing section 1311. Aportion of tubing section 1311 extending through end cap 1309, balloon1307 and tubing 1201 may retain a circular cross section even when clamp1202 is closed.

FIG. 13B shows illustrative apparatus 1302. Apparatus 1302 shows across-section of apparatus 1300 taken along lines 2-2 shown in FIG. 12.Apparatus 1302 shows outer tubing 1201 and inner tubing 1311. Fluid forinflating balloon 1307 may flow in a space between outer tubing 1201 andinner tubing 1311.

Inner tubing 1311 may include a compressible segment and anon-compressible segment. Balloon 1307 may extend along anon-compressible segment of inner tubing 1311. A shoulder 1310 may bepositioned about a compressible segment of inner tubing 1311. Acompressible segment of inner tubing 1311 may be anastomized to conduit1213 (shown in FIG. 12).

Apparatus 1302 shows end cap 1309 sealing and end of balloon 1307.Apparatus 1302 shows that end cap 1309 may provide a “seat” forpositioning rotatable arm 1203 relative to an anastomosis site.

FIG. 14 shows illustrative view 1400 of apparatus 1301 (shown in FIG.13A). View 1400 shows a first segment of inner tubing 1311 having atubular diameter of d1. Inner tubing 1311 may be configured to transportfluid siphoned off from conduit 1213. Diameter d1 may be selected basedon a diameter of d2 of conduit 1213. Diameter d1 may be selected toobtain a target throughput of fluid when clamp 1203 is open.

Fluid may be present in a space between outer tubing 1201 and innertubing 1311. The fluid present in the space maybe saline, water or anysuitable fluid for inflating balloon 1307.

FIG. 15A shows illustrative therapeutic scenario 1500. Scenario 1500shows an illustrative anastomization of tubing 1504 to conduit 1519.Conduit 1519 may be a blood vessel. Tubing 1504 may include flared ends1509 and 1511. Flared ends 1509 and 1511 may be anastomized to conduit1519 using sutures 1515 and 1517.

Scenario 1500 shows a portion of a clamp positioned over tubing 1504.The clamp includes rotatable arms 1503 and 1501. Rotatable arm 1503 ispositioned within sleeve 1513. Sleeve 1513 is formed from flared end1511 and outer wall 1505 of tubing 1504. Sleeves may be formed from anysuitable material such as Dacron, Gore-Tex, polytetrafluoroethylene(“PTFE”), fluoropolymer products and any material suitable forimplantation in a human body. Flared end 1511 may include materialsubstantially perpendicular to outer wall 1505 and materialsubstantially parallel to outer wall 1505.

Rotatable arm 1501 is positioned within sleeve 1507. Sleeve 1507 may beformed from flared end 1509 and outer wall 1506 of tubing 1504. Flaredend 1509 may include material substantially perpendicular to outer wall1506 and material substantially parallel to outer wall 1506.

A sleeve may take on different shapes. A sleeve may be constructed witha shape to decrease its footprint in a transverse dimension. Forexample, arms 1501 and 1503 may each be retracted slightly superiorly tothe anastomosis site. Inferior aspects of outer wall 1505 may be fusedto material 1513. Inferior aspects of outer wall 1506 may fused tomaterial 1507. This would allow the device to have a thinner overalltransverse dimension at the anastomotic site but still maintain a tightseal when arms 1501 and 1503 close about tubing 1504.

When the clamp is in an open position, rotatable arms 1503 and 1501 maybe separated by gap G. Gap G may allow a fluid carried by conduit 1519to enter tubing 1504. When the clamp is in a closed position, outerwalls 1505 and 1506 may be compressed to eliminate gap G. Outer walls1505 and 1506 maybe compressed so that flared end 1511 is substantiallyflush with flared end 1509.

FIG. 15B shows illustrative view 1502 taken along line 2-2 shown in FIG.11. View 1502 shows rotatable arms 1103 and 1105 crimping tubing 1111.O-ring 1107 may bias rotatable arms 1103 and 1105 to crimp tubing 1111.The crimping of tubing 1111 may collapse a lumen of tubing 1111. Thecrimping of tubing 1111 may seal tubing 1111 by pressing outer walls oftubing 1111 flush with each other.

Inflating a balloon positioned underneath rotatable arms 1103 and 1105may allow tubing 1111 to expand and reopen a lumen through tubing 1111.

FIG. 16 shows illustrative reservoir 1600. Reservoir 1600 may beimplanted in a human body. Reservoir 1600 includes septum 1611. Septum1611 may include a self-sealing membrane. A needle may penetrate septum1611 to access contents of reservoir 1600. Reservoir 1600 may beimplanted subcutaneously. The needle may penetrate human tissue beforepenetrating septum 1611. Retainer ring 1601 may secure septum 1611 toreservoir 1600.

Fluid may pool in a first chamber of reservoir 1600. The first chambermay be defined, at least in part, by housing 1605. Retainer ring 1601may secure septum 1611 to reservoir 1600 and prevent a leakage ofcontents out of the first chamber.

Reservoir 1600 includes barb 1603. Barb 1603 provides fluidcommunication into housing 1605. Barb 1603 may be inserted into tubing,such as tubing 1101 (shown in FIG. 11). Fluid may be inserted into thefirst chamber via barb 1603. Fluid may be extracted from first chambervia barb 1603.

Fluid may pool in second chamber enclosed, at least in part, by housing1609. The second chamber may not be in fluid communication with firstchamber. A platform (not shown) may fluidly seal the first chamber fromthe second chamber.

Fluid may be inserted into the second chamber via barb 1607. Fluid maybe extracted from the second chamber via barb 1607. Barb 1607 may beinserted into tubing, such as tubing 1201.

FIG. 17 shows exploded view 1700 of reservoir components. View 1700includes retainer ring 1701.

Retainer ring 1701 may be positioned over septum 1703. Retainer ring1701 may fluidly seal septum 1703 to housing 1705. Septum 1703 may bepositioned over first housing 1705. First housing 1705 may define, atleast in part, a first chamber of a reservoir. Fluid contents of thefirst chamber may be accessed using barb 1707.

View 1700 includes platform 1709. Platform 1709 may be moveable.Platform 1709 may translate within housing 1705. Platform 1709 maytranslate within housing 1713. Movement of platform 1709 may expand thefirst chamber. Movement of platform 1709 may contract the secondchamber. Movement of platform 1709 may draw fluid into housing 1705 viabarb 1707. Movement of platform 1709 may expel fluid from housing 1713via barb 1715. Expelling fluid from housing 1713 may induce hydraulicpressure in a tubing connected to barb 1715. The hydraulic pressure maybe directed by the tubing to inflate a balloon affixed to the tubing.

Platform 1709 may be encircled by sealing ring 1711. Sealing ring 1711may prevent housing 1705 from mixing with fluid in housing 1713. Sealingring 711 may fluidly seal a first chamber of the reservoir from a secondchamber of the reservoir.

Platform 1709 includes extension 1712. Extension 1712 may fit into bore1717. Extension 1712 and bore 1717 may center platform 1709 with respectto housing 1713. Extension 1712 and bore 1717 may maintain contactbetween sealing ring 1711 and an inner wall of housing 1713.

Extension 1712 may be configured to translate within bore 1717.Extension 1712 may translate within bore 1717 in response to pressureapplied to platform 1709. For example, a needle that penetrates septum1703 may apply pressure to platform 1709. The pressure may expand afirst chamber of the reservoir and contract a second chamber of thereservoir.

Extension 1712 may translate within bore 1717 in response to pressureexerted by spring 1718. Spring 1718 may bias platform 1709 againstseptum 1703. For example, a needle that penetrates septum 1703 may applypressure to platform 1709. In response to a decrease in pressure appliedto platform 1709 by the needle, platform 1709 may be pushed towardseptum 1703 by spring 1718.

Reservoir 1700 includes bladder 1710. Bladder 1710 may be filled with afluid. The fluid may be water, saline or any suitable fluid. Bladder1710 may be compressible. Bladder 1710 may be compressed by movement ofplatform 1709. Platform 1709 may compress bladder 1710 against a floorand/or inner wall of housing 1713.

Compression of bladder 1710 may expel fluid from bladder 1710. Theexpelled fluid may exit housing 1713 through barb 1715. The expelledfluid may pressurize a tube connected to barb 1715.

Reservoir 1700 includes bushing 1719. Bushing 1719 includes protrusions1721. Protrusions 1721 may be configured to engage guide 1725 in washer1723. Protrusions 1721 may be configured to engage teeth (not shown) inbore 1717. Protrusions 1721 may lock a position of platform 1709 withrespect to septum 1703. Bushing 1719 may be configured to rotate aboutextension 1712.

FIG. 18 shows illustrative view 1800 of reservoir 1700. View 1800includes extension 1712. View 1800 shows bushing 1719. Busing 1719includes protrusion 1721. Housing 1713 includes deep wells 1809 andshallow wells 1811. When protrusion 1721 is seated in a deep well,platform 1709 may be pressed against septum 1703. When protrusion 1721is seated in a shallow well, platform 1709 may compress bladder 1710.

Protrusion 1721 may be moved from a deep well by pressure applied toplatform 1709. For example, a needle inserted through septum 1703 mayapply pressure to platform 1709. In response to the pressure, protrusion1721 may be shifted from a deep well to a shallow well by guide 1725.

FIG. 19 shows illustrative cross-sectional view 1900 taken along lines3-3 shown in FIG. 16. View 1900 includes septum 1611. Septum 1611 may befluidly sealed to housing 1605 by retainer ring 1601.

Platform 1909 may receive a needle inserted through septum 1611 indepression 1925. The needle may push platform 1901 toward floor 1909 ofhousing 1609. Movement of platform 1901 may expand chamber 1923.Movement of platform 1901 may compress bladder 1914 against floor 1923.

Fluid may pool in chamber 1923. Fluid may be prevented from leaking outof chamber 1923 by a seal formed by septum 1611 and retainer 1601.

The fluid in chamber 1923 may include blood that enters chamber 1923from a tubing (not shown) affixed to barb 1603. Barb 1603 may beinserted into a bore in housing 1605. Fluid in chamber 1923 may beprevented from leaking in to housing 1609 by seal 1905. Seal 1905 may besecured by retainer 1907. In some embodiments, platform 1901 may includeretainer 1907.

View 1900 includes bladder 1914. Bladder 1914 may be filled with aliquid. Bladder 1914 may be compressed between platform 1901 and floor1909 of housing 1609.

View 1900 shows extension 1913 of platform 1901. Extension 1913 may beconfigured to fit into bushing 1915. Bushing 1915 may includeprotrusions, such as protrusions 1721 of bushing 1719 (shown in FIG.17). Bushing 1915 may rotate about axis Z when protrusions of bushing1915 are shifted between deep wells and shallow wells of housing 1609.Movement of platform 1901 may shift the protrusions between deep andshallow wells.

In some embodiments, extension 1913 may include a flange. The flange maykeep bushing 1915 fixed longitudinally along axis z with respect toextension 1913. The flange may allow bushing 1915 to rotate about axis Zin response to a shifting of the protrusion between deep and shallowwells.

View 1900 includes washer 1911. Washer 1911 includes guides 1910. Guides1910 align a protrusion of bushing 1915 with a deep or shallow well ofhousing 1609.

When a protrusion of bushing 1915 is positioned in a deep well, bladder1914 may expand to default size. When a protrusion of bushing 1915 ispositioned in a shallow well, bladder 1914 may be compressed. When aprotrusion of bushing 1915 is positioned in a shallow well, platform1901 may be locked in a position that compresses bladder 1914. Pressureapplied to platform 1901 may shift a protrusion of bushing 1915 into adeep well, unlocking platform 1901. When unlocked, a spring or othersuitable biasing member (not shown) may push platform 1901 toward septum1611 and contract chamber 1923.

In some embodiments, prior to unlocking platform 1901, chamber 1923 maybe filled with fluid. The fluid within chamber 1923 may prevent platform1901 from contacting septum 1611. For example, blood may pool in chamber1923. The blood may be extracted from chamber 1923 during a dialysisprocedure. At a conclusion of the dialysis procedure, hepranized salinemay be injected into chamber 1923 and tubing affixed to barb 1603. Thehepranized saline may prevent clots from forming in chamber 1923 and thetubing affixed to barb 1603.

FIG. 20 shows illustrative system 2000. System 2000 includes clamp 2011.System 2000 includes tubing 2009. System 2000 includes adapter 2003.Adapter 2003 includes branch 2005 and branch 2007. Branch 2005 may beaffixed to barb 2006 of reservoir 2001. Branch 2007 may be affixed tobarb 2008 of reservoir 2001.

A needle may be inserted through a septum in reservoir 2001. The needlemay apply pressure to a moveable platform within reservoir 2001 andthereby compress a bladder within reservoir 2001. Compression of thereservoir may expel fluid from the bladder into branch 2007 and tubing2009.

The expelled fluid may inflate a balloon and open clamp 2011. Openingclamp 2011 may open a portion of tubing 2009 anastomized to conduit2013. Opening clamp 2011 may allow blood or other fluid flowing withinconduit 2013 to enter tubing 2009. The blood or other fluid may be drawnfrom conduit 2013 into tubing 2009. The blood or other fluid may flowthrough branch 2005 and into reservoir 2001. The needle may be used toextract the blood or other fluid from reservoir 2001. A system mayinclude one or more of systems 2000.

FIG. 21 shows illustrative apparatus 2100. Apparatus 2100 includes clips2109 and 2107. Clips 2109 and 2107 are affixed to tubing 2111. Apparatus2100 includes clamp 2101. Clamp 2101 includes clips 2103 and 2105. Insome embodiments, tubing 2111 may be anastomized to a conduit. After theanastomization procedure, clamp 2101 may be slipped over tubing 2111 andpositioned relative to the conduit. The clamp may be positioned abuttingthe conduit or near the conduit.

The clamp may be locked in a position relative to the conduit byengagement of clip 2103 of the clamp and clip 2107 of the tubing. Theclamp may be locked in a position relative to the conduit by engagementof clip 2105 of the clamp and clip 2109 of the tubing. Some embodimentsmay only include one set of clips such as clips 2109 and 2105. Someembodiments may include two or more sets of clips.

FIG. 22A shows illustrative apparatus 2200. Apparatus 2200 includespocket 2201. Cantilever arm 2203 may be positioned inside pocket 2201.Pocket 2201 may position cantilever rod 2203 against tubing 2221.Apparatus 2200 includes annular ring 2205. Annular ring 2205 may presscantilever arm 2203 against tubing 2221. Tubing 2221 may include anon-compressible segment underneath annular ring 2205.

Tubing 2221 may include a compressing segment 2219. Pressing cantileverarm 2203 against compressible segment 2219 may close a lumen of tubing2221. Closing the lumen of tubing 2221 may seal tubing 2221 from fluidflowing in conduit 2223.

Cantilever arm 2203 includes angled segment 2202. Angled segment 2202may be fitted into hinges 2213 and 2215. Hinges 2213 and 2215 may beaffixed to panels 2211 and 2209. In some embodiments, panels 2211 and2209 may be inserted into a sleeve affixed to the anastomosis site. Thesleeve may prevent components of apparatus 2200 from contacting bodilytissue. The sleeve may position cantilever arm 2203 and angled segment2202 relative to tubing 2221 and/or conduit 2223.

Apparatus 2200 includes hydraulic tract 2207. Hydraulic tract may carrya hydraulic fluid such as water. Hydraulic tract 2207 may terminate in aballoon segment (not shown). The balloon segment may be inflated byincreasing hydraulic pressure inside hydraulic tract 2207. The balloonsegment may extend between tubing 2221 and annular ring 2205. Theballoon segment may extend alongside tubing 2221 from annular ring 2205to a junction of cantilever arm 2203 and angled segment 2202.

When the balloon segment is inflated, cantilever arm 2203 may pushangled segment 2202 away from tubing 2221. Angled segment 2202 move awayfrom tubing 2221 by rotating panels 2211 and 2209 about hinges 2213,2215, 2225, 2227, 2229 and 2231. Pushing angled segment 2202 away fromtubing 2221 may open a lumen in tubing 2221 placing tubing 2221 in fluidcommunication with contents of conduit 2223. Apparatus 2200 may includetwo or more cantilever arms and associated angled segments.

FIG. 22B shows an illustrative cross-section of apparatus 2200 takenalong lines 4-4 when balloon segment 2235 is in a deflated state. FIG.22C shows an illustrative cross-section of apparatus 2200 taken alonglines 4-4 when the balloon segment 2235 is in an inflated state.

FIGS. 23A-23B show illustrative process 2300. For the sake ofillustration, one or more of the steps of the process illustrated inFIG. 23 will be described as being performed by a “system.” The “system”may include one or more of the features of the apparatus, arrangementsinformation or processes shown in FIGS. 1-22 and/or any other suitabledevice or approach.

The “system” may be a computer or robotic system. For example, asubcutaneous reservoir may include circuitry for directing a roboticallycontrolled needle into a septum of the reservoir. The system may provideautomated dialysis of a patient's blood.

Process 2300 begins at step 2301. At step 2301, the system inserts aneedle into septum of a first reservoir coupled to an artery of apatient. At step 2303, the system expands a first chamber of the firstreservoir and contracts a second chamber of the first reservoir bypressing the needle against a moveable platform between the firstchamber and the second chamber.

At step 2305, hydraulic pressure is generated by compressing themoveable platform against a liquid filled bladder within the secondchamber. At step 2307, the system continues to press the needle againstthe moveable platform until the moveable platform locks in positioncompressing the bladder.

At step 2309, the hydraulic pressure opens a clamp that is biased tocompress a resilient segment of tubing anastomized to the blood vessel.

At step 2311, blood begins to flow from the blood vessel into the firstchamber. At step 2313, using needle, the system extracts blood from thefirst chamber. At step 2315, the system transfers the blood extractedfrom the first chamber to a dialysis machine. At step 2317, the systemfilters the extracted blood. At step 2319, the system transfers thefiltered blood to a second reservoir. The first and second reservoir maybe coupled to arteries, veins or any suitable combination of bloodvessels. At step 2321, the system returns the filtered blood tocirculation within the patient via hydraulically controlled accesscoupled to the second reservoir.

At step 2321, the system presses a needle against the moveable platformto further expand the first chamber of the first reservoir and furthercontract the second chamber of the first reservoir thereby unlocking themoveable platform. At step 2323, a biasing member of the reservoircollapses the first chamber of the reservoir. At step 2325, as a resultof the expansion that second chamber, the bladder fills with fluid anddecreases the hydraulic pressure allowing the balloon to deflate. Atstep 2327, the clamp closes upon a resilient segment of tubing therebysealing the blood vessel from the graft. The clamp may be positioned toseal the tubing in a manner that preserves substantially uniform bloodflow through the blood vessel across the site of the anastomization atstep 2329.

FIG. 24 shows an illustration of a clamp manipulator 2400, which aloneor as a component of an overall lumen clamping means, comprises a firsttab 2401 which may be rotatably attached to an axial support member2402, and in a preferred embodiment contains a second tab 2403 which mayalso be rotatably attached to an axial support member 2404. There may bean elastic, or other suitable material, tab shield 2405 serving as acovering for the purpose of shielding the area traversed by said tabs2401 and 2403. Additionally, the tab shield 2405 may serve to provideretractive forces, causing the tabs 2401 and 2403 to return to theirinitial position, following use. The tabs may be arranged to be coupledwith, or to engage a gear assembly 2406.

This figure shows first tab 2401 and second tab 2403 as rectangular inprimary shape, however, this shape is only for illustrative purposes tobe able to clearly show the structure of the tab as well as the tabshield 2405. It can be appreciated by those skilled in the art, that theshape may well be a semicircle or an irregular parabolic-type of designwith straying from the concept of this component disclosure; the ease ofuse, patient comfort, and ease of manufacture will lead to varioussatisfactory shapes contemplated by this disclosure.

FIG. 25 shows an end view illustration of a clamp manipulator 2500,which may have one or more features of the clamp manipulator 2400 (shownin FIG. 24) and the gear assembly 2501, which may have one or morefeatures of the gear assembly 2406 (shown in FIG. 24). The directions ofpressing the first tab 2502 and the second tab 2503 can be seen. The tabmay have a substructure suitable for the transfer of the tabs to thegear assembly 2501. In a preferred embodiment, the substructure mayinclude an inner gear assembly 2504 or an outer gear assembly 2505, orboth. Additionally, the gear assembly 2501 may have a left-side drivegear 2506 and a right-side drive gear 2507, arranged to take power fromthe outer gear assembly 2505 or the inner gear assembly 2504, or both.The left-side drive gear 2506 and right-side drive gear 2507 are botharranged to drive central gear 2508. This gear arrangement is meant todescribe possible motion, and placement of power transfer mechanisms.Those skilled in the art can appreciate the various mechanisms and gearcombinations that might achieve this basic goal, and those embodimentare intended to be encompassed in this disclosure.

FIG. 26 shows an illustration of a fluid driven member 2600, which mayhave one or more features of the clamp manipulator 2500 (shown in FIG.25). Specifically, a central gear 2601 is arranged (similarly to centralgear 2508, shown in FIG. 25) to drive or otherwise energize the fluiddriven member 2600. The central gear 2601 is arranged in a preferredembodiment to couple with a longitudinal screw gear 2602, wherein thelongitudinal screw gear 2602 acts on the pressurized fluid 2603contained in said fluid housing tube 2604. The pressure is modulated bythe movement of a plunger 2605, or other moveable sealing apparatus. Thestructure of the assembly may be reinforced through components such ascentral cross-member 2607; such central cross member 2607 may be affixedto the device lumen 2608 (see 2410, for example; in FIG. 24).

FIG. 27A shows an illustration of the needle receptor 2701 coupled withthe device lumen 2702, wherein the device lumen is shown traversing thetabs 2703 (see the similar tabs also at number 2401 and 2403, in FIG.24; and tabs also at number 2502 and 2503, in FIG. 25) and the tabs arecoupled to the gearing means 2704 (see also the similar gearing means atnumber 2406, in FIG. 24) which is in-turn coupled to the fluid drivenmember 2705 (see also the fluid driven member 2600, in FIG. 26). Thisembodiment may contain one or more features of each of these referencedfigures and the embodiments related thereto.

Additionally, this embodiment shows the needle receptor 2701 with itspositioning means 2710 component. The positioning means 2710 includes ina preferred embodiment, a rotating member 2711 which in-turn has anangular protrusion 2712 and a channel 2713. The needle receptor 2701 hasa funnel-shaped entry site 2720, which is wide enough to provide a broadzone for a successful needle stick. Once the needle 2721 is passedthrough the skin and into the funnel-shaped entry site 2720 it is guidedas it progresses toward the angular protrusion 2712. The surface thatengages the needle 2721 first upon a nearly perpendicular (a high anglewith the skin surface) may include an irregularity in the form of asloping inclination 2722, this irregularity serves to direct the needle2721 toward the conic-base of the funnel-shaped entry site 2720.Following the leading edge of the angular protrusion 2712, the needlenext encounters a channel directing detente 2723. This detent 2723serves the further guide the needle into the channel 2713 by causing aslight rotation of the rotating member 2711; thereby ensuring that thetip of needle 2721 will intersect the channel 2713 opening.

Once the needle 2721 begins to enter the channel 2713, the needle 2721causes the continued rotation of the rotating member 2711. At theinstance of near total alignment of the needle 2721 with the channel2713, the needle 2721 will slide into the tight-fitting channel 2713;thereby causing a friction fit seal. It is also contemplated thatcoatings, sealing agents, and dissimilar materials (these variousadditions are not shown here) may be beneficial to this sealing action,and they are within the contemplation of this disclosure.

FIG. 27B shows an illustration of the needle receptor 2750, which mayhave one or more features of the needle receptor 2701 (shown in FIG.27A). This illustration shows the needle 2751 after it has come intoalignment with the channel 2752 following the rotation of the rotatingmember 2753. The needle 2751 is in fluid communication with the devicelumen 2754. In this position the needle 2751 should be in substantialcontact with the channel 2752, such that there is no fluid leakage fromthe device lumen 2754.

FIG. 28 shows an illustration of the lumen clamping means 2800. Thisillustration shows a first clamp arm 2801 acting in concert with asecond clamp arm 2802, to compress a device lumen 2803. The device lumen2803 is released from the first clamp arm 2801 and the second clamp arm2802, and open to flow from the native lumen 2805, as the wedge member2804 is pressed between the first clamp arm 2801 and the second clamparm 2802. The wedge member 2804 is driven by the fluid driven member2850. The fluid driven member 2850 may have many of the characteristicsand elements of fluid driven member 2600 (see FIG. 26).

FIG. 29 shows an illustration of a preferred embodiment of a clampmanipulator 2900. This clamp manipulator may have many features andcharacteristics of clamp manipulator 2400 (see FIG. 24).

This clamp manipulator 2900 may be activated by pressing tab 2901simultaneously with tab 2902. A first external ring-gear 2903 is coupledwith tab 2901 (coupling is not shown) such that the angular motion oftab 2901 is translated as circular motion of said first externalring-gear 2903. Similarly, second external ring-gear 2904 is coupledwith tab 2902 (coupling is not shown) such that the angular motion oftab 2902 is translated as circular motion of said second externalring-gear 2904. A gearing mechanism is arranged to combine the power ofsaid first external ring-gear 2903 with the power of said secondexternal ring-gear 2904 (not shown). A follower ring 2905 may be used tosupport the tab 2901 at the end opposite from external ring-gear;similarly, a follower ring 2906 may be used to support the tab 2902 atthe end opposite from external ring-gear 2904.

FIG. 30A shows an illustration of the gear means 3000. The gear means3000 may share one of more features of the first external ring-gear 2903and the second external ring-gear 2904 (shown in FIG. 29). This gearmeans 3000 is arranged to transfer power from the tabs (not shown) tothe fluid driven member 3020. This energy transfer is accomplished viathe rotation of first external ring-gear 3051 and the second externalring-gear 3053, because of the orientation with the tabs (not shown, butsee FIG. 29) the first external ring-gear 3051 and the second externalring-gear 3053 rotate in opposite directions. The rotative power becomescumulative after the first external ring-gear 3051 and the secondexternal ring-gear 3053 mesh with the slave gear 3052 and the primarydrive gear 3054, respectively; whereupon the slave gear 3052 furthermeshes with the primary drive gear 3054. Thus, the power is cumulated bythe gear means 3000 and delivered to the fluid driven means 3020.

FIG. 30B shows an end-view illustration of the gear means 3050. Thisillustration repeats many elements of FIG. 30A, for the purposes ofgeneral illustration as well as a clarification of the spatialrelationship of the individual component gears and their interactions.Elements depicting the same component are numbered the same as in FIG.30A, however a prime indicator has been added to enable continuity fromfigure to figure while having a distinction. This view shows clearly themeshing of the first external ring-gear 3051′ with the slave gear 3052′;this view together with the view of the slave gear 3052 (see FIG. 30A)demonstrates that the slave gear 3052′ does not contact or mesh with thesecond external ring-gear 3053. However, this figure demonstrates thatthe slave gear 3052′ does mesh with the primary drive gear 3054′; whichprimary drive gear 3054′ does mesh with the second external ring-gear3053.′

FIG. 31 shows an illustration of the needle receptor 3101, the clampmanipulator 3100, and the portion of the clamp manipulator 3100 referredto in certain embodiments as the gear means 3102 (see, for example,element 3000, at FIG. 30A, and element 3050, at FIG. 30B); the clampmanipulator repeats many features and characteristics of thesereferenced elements. This figure demonstrates the configuration ofassembly and interrelatedness of the clamp manipulator 2900 (see FIG.29) with the gear means 3000 (see FIG. 30A and FIG. 30B) and how theyperform together to drive the fluid driven member 3020 (see FIG. 30A).The tab 3110 can be seen relative to first external ring-gear 3111,which transfer the downward force from the fingers of the operator (notshown); which will travel to the slave gear 3115, and then to theprimary drive gear 3116. The primary drive gear also receives force fromthe second external ring-gear 3112, which is transferred unto it fromthe second tab (not shown, but see tab 2901 and tab 2902, at FIG. 29).This cumulative power is delivered from the gear means 3102 to the fluiddriven tube 3117 (see for example element 2600, at FIG. 26).

FIG. 32 shows an illustration of the needle receptor 3201 having afunnel opening 3205, the clamp manipulator 3200, and the portion of theclamp manipulator referred to in certain embodiments as the one or moretabs 3210, the palpable button 3215. This figure also shows the needle3221, in place for insertion into the funnel opening 3205. Also depictedare tension element 3241 connected to clamp arms 3250 configured toclamp the lumen 3260 at a point adjacent to the anastomosis with theblood vessel.

FIG. 33 depicts the needle 3321 having been advanced into the needlereceptor 3301 through the funnel portion 3305. With the needle insertedinto the needle receptor 3301, the palpable button 3315 may be depressedin the direction indicated by arrow 33A, so that the palpable button ismoved from a first state to a second state. When the button 3315 is in afirst state, it is configured to mechanically prevent movement of one ormore tabs 3310. However, once button 3325 is in a second state, the oneor more tabs 3310 may then be actuated by pressing in the tab, asrepresented by arrow 33B. In embodiments having two tabs on opposingsides of the clamp manipulator 3300, corresponding forces may be appliedto squeeze both tabs 3310 at the same time, to actuate the mechanicallinkages (as depicted in FIGS. 34 and 37) within the clamp manipulator3300. Actuation of the clamp manipulator 3300 will cause tension element3341 to be pulled in a proximal direction as depicted by arrow 33C,whereupon the clamp arms 3350 are opened, as depicted by arrows 33E toallow fluid flow through the lumen 3360. As the clamp arms 3350 areurged open, a clamp spring 3355 is energized, such that clamp springwould urge the clamp arms to a closed position, but for the tensionapplied via tension element 3341. The clamp actuator 3300 additionallyis mechanically linked to the funnel portion 3305 of needle receptor3301, such that as the one or more tabs 3310 are pressed, the funnelportion is urged in a distal direction, as shown by the force arrows33E.

FIG. 34 depicts a cross-section view of the internal elements of theneedle receptor 3401, and the clamp manipulator 3400. The needle 3421 isdepicted as having been advanced through the mouth of the funnel 3405,and through the elastic sealing material 3465, and displacing a springmounted sealing rod 3464. The needle receptor 3401 provides, in thisembodiment, 2 paths for alternating needle penetration when the bloodsystem is being accessed, so as to afford healing of the skin subsequentto needle penetration, prior to the subsequent access. The needle 3421enters along an axis the intersects tangentially with a sphericalchamber 3470, which is in fluid communication with the lumen 3460. It iscontemplated that the spherical chamber 3470 may alternatively be anon-spherical shape, for example ovoid, but in any embodiment, it ispreferred that sharp corners are avoided, so as to avoid eddies orpoorly flowing regions in the chamber that would otherwise promoteclotting or biological build up in the poorly flowing region. It isrecognized that a spherical chamber, having tangentially located ports3471, promotes even flow through the entirety of the chamber, during theperiod of time when blood is flowing through the device, andadditionally upon being flushed with saline, will effectively flush theblood material from the device, such that the closed volume, when notbeing accessed remains filled with the saline flush. FIG. 34 furtherdepicts the one or more tabs 3410, which upon being released formovement by the pressing of the palpable button (not shown), each of thetabs 3410, being palpable through the skin, may be urged by the operatorto move, and overcome the resistance of tab spring, The movement of thetab 3410, in turn, acts upon mechanical linkages a portion of which isshown in FIG. 34, where first rigid link 3412, connected to the tab viafirst pivot 3413. The mechanical output from pressing upon tabs 3410 isdepicted in FIG. 35.

FIG. 35 depicts the needle receptor 3501 and clamp manipulator 3500. InFIG. 35, the one or more tabs 3510 are depicted as having been pressedand moved inwards towards the spherical chamber 3570, in the directiondepicted by arrow 35A. The movement of the one or more tabs 3510, inturn acts upon a series of mechanical linkages to cause the funnel 3505of the needle receptor to move in the direction depicted by arrows 35B,and applying compressive force to elastic sealing material 3565, whichdue to being constrained from movement by the construction of the clampmanipulator 3500, responds by compressing axially, as depicted by thearrows 35C, thereby forming a seal around the needle 3521. The movementof the one or more tabs 3510 is similarly conveyed by mechanicallinkages to cause the clamp to open, as will be discussed.

FIG. 36 depicts one embodiment of the subcutaneously implanted devicewhile in a state allowing blood flow therethrough. In this embodiment,the one or more tabs 3610 are urged inwards, as previously discussed,and the funnel 3605 has been urged against sealing material 3665 to sealtightly around needle 3621. Additionally, clamp arms 3650 have beencaused to open, such that there is now fluid communication between thenative body blood vessel, the lumen 3660, the spherical chamber 3670,and the interior of the needle 3621. In this manner, blood is able toflow through the fluid pathway, to allow a medical procedure, such asdialysis to occur. By using two devices in tandem, it is anticipatedthat blood could be withdrawn from an anastomosis with the arterialsystem, or a graft, flow through the subcutaneously implanted device,and be delivered to a dialysis machine outside of the body. After theblood is filtered or treated, the blood may be returned through a seconddevice anastomosed to a venous system, or graft, such that the bloodflows through the needle, then through the lumen, and to the venoussystem. It is contemplated that in a less preferred use, the directionof flow through the device may be reversed after a period of time, wherean amount of blood is removed from the patient, treated, and returnedthrough the same device back into the blood system of the patient.

FIG. 37 is different view of the device in the same condition depictedin FIG. 36, and depicts the clamp arms 3750 having been opened by theaction the one or more tabs 3710, acting via mechanical linkagescomprising at least a second rigid link 3744, which is secured to thebody of the tab at one end, and to a cable puller 3742 at the other end.The second rigid link 3744 serves to transfer the movement of the tab3710 into a proximally directed (in a direction away from theanastomosis) movement of puller 3742. The proximally directed movementof the puller in turn pulls on the tension element 3741, which may be acable or tension rod. The tension element 3741 is secured at its distalterminus to a fixation element 3743, and acts in cooperation with theclamp arms, to open the clamp arms as the fixation element is movedproximally. This may be accomplished, for example, by pins or protrudingelements (as can be seen with reference to FIG. 1) affixed to thefixation element 3743, that ride in cam slots 3745 in the clamp arms3750, such that the pins riding in the angled cam slots 3745 force theclamp arms to open, when the puller 3742 is moved proximally, It isunderstood that a variety of mechanical linkage arrangement mayalternatively be utilized to clause the clamp to open, and in light ofthis teaching, those of ordinary skill in the art can generateadditional embodiments and modifications without departing from thespirit of or exceeding the scope of the principles of the invention.

FIG. 38 depicts the device actions to be performed after the medicalprocedure, typically blood dialysis, has been completed, and the fluidpathway has been preferably flushed with saline, or any other suitablefluid to clear the pathway. In order to seal off the lumen 3860, theuser depresses the palpable button 3815 in the direction shown by arrow38A, causing the button to revert from the second state to the firststate. While the button remained in the second state, the inwardmovement of the one or more tabs was restrained; and as the buttonenters the first state, the tabs are urged back to their originalposition by the springs (see tab springs 3411 of FIG. 34). The movementof the tabs to their original position reverses the movement of themechanical linkages described previously, such that the clamp arms arecaused to clamp and seal the lumen 3860, as the tension upon the tensionelement is released (represented by the arrow 38B, and the puller 3842returns to its original position. Additionally, the tab movement allowsthe ring seal formed by the elastomeric material around the needle 3821to release, as the funnel portion 3805 is moved proximally in thedirection shown by arrow 38C. As needle 3821 is withdrawn, the springloaded sealing rod 3864 is urged against the retreating needle, untilsuch a point as the sealing rod is through the sealing material, therebycompleting a seal in the proximal end of the fluid pathway while thedevice remains in an idle position. Apparatus and methods describedherein are illustrative. Apparatus and methods of the invention mayinvolve some or all of the features of the illustrative apparatus and/orsome or all of the steps of the illustrative methods. The steps of themethods may be performed in an order other than the order shown anddescribed herein. Some embodiments of the invention may omit steps shownand described in connection with the illustrative methods. Someembodiments of the invention may include steps that are not shown anddescribed in connection with the illustrative methods.

The invention may be operational with numerous other general purpose orspecial purpose computing system environments or configurations. Forexample, control of expandable, contractible and otherwise moveableapparatus may be controlled by a computer system. Examples of well-knowncomputing systems, environments, and/or configurations that may besuitable for use with the invention include, but are not limited to,personal computers, server computers, hand-held or laptop devices,mobile phones and/or other personal digital assistants (“PDAs”),multiprocessor systems, microprocessor-based systems, set top boxes,programmable consumer electronics, network PCs, minicomputers, mainframecomputers, distributed computing environments that include any of theabove systems or devices, and the like. In a distributed computingenvironment, devices that perform the same or similar function may beviewed as being part of a “module” even if the devices are separate(whether local or remote) from each other.

The invention may be described in the general context ofcomputer-executable instructions, such as program modules, beingexecuted by a computer. Generally, program modules may include routines,programs, objects, components, data structures, etc., that performparticular tasks or store or process data structures, objects and otherdata types. The invention may also be practiced in distributed computingenvironments where tasks are performed by separate (local or remote)processing devices that are linked through a communications network. Ina distributed computing environment, program modules may be located inboth local and remote computer storage media including memory storagedevices.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theprinciples of the invention. Accordingly, it is to be understood thatthe drawings and descriptions herein are proffered by way of example tofacilitate comprehension of the invention and should not be construed tolimit the scope thereof. Persons skilled in the art will appreciate thatthe present invention can be practiced by other than the describedembodiments, which are presented for purposes of illustration ratherthan of limitation.

Thus, systems and methods for hydraulically controlled arterial/venousaccess, as well as mechanical linkage enabled arterial/venous access,have been provided. Persons skilled in the art will appreciate that thepresent invention can be practiced by other than the describedembodiments, which are presented for purposes of illustration ratherthan of limitation. The present invention is limited only by the claimsthat follow.

What is claimed is:
 1. A subcutaneous vascular access device designedfor repeated use comprising: At least a first needle receptor, whereinsaid first needle receptor is located on a proximal end of said vascularaccess device and is arranged to accept a needle having a distal tipthat is inserted from outside the body, and to provide positioning meansfor the alignment of said needle; a lumen having at least a firstlocation, second location and third location, wherein said lumen isarranged to contact said needle receptor at said first location and withsaid lumen being arranged to be anastomosed to a native body lumen atsaid second location, with said second location also serving as a distalend of said vascular access device; a lumen clamping means comprising:at least two clamping members arranged to compress said lumen at saidthird location between said first location and said second location,thereby sealing said lumen between said anastomosis and said firstlocation, and prohibiting fluid communication with said native bodylumen; a mechanically driven member arranged to be energized to causediametrically opposed motion of the said at least two clamping members,thereby decompressing said lumen to provide fluid communication betweensaid native body lumen and said first location; and a clamp manipulatorcomprising at least a first tab mechanically linked to said mechanicallydriven member, wherein the depressing of said first tab causes saidmechanically driven member to be energized.
 2. The device of claim 1,wherein said positioning means comprises: a funnel shaped membercomprising: a gradually decreasing opening arranged to slidably acceptsaid distal tip of said needle, wherein said opening serves to centersaid needle relative to said funnel shaped member; a channel arranged toslidably accept said needle following the alignment of said needle withsaid channel upon centering in said funnel shaped member, whereupon saidneedle may be inserted into said channel; a sealing means located insaid channel, wherein said sealing means serves to seal any gaps betweensaid needle and said channel, with said channel being in fluidcommunication with said lumen.
 3. The device of claim 2, wherein saidsealing means is further arranged to coaxially and slidably encompass apush member, wherein said push member provides resistance to slidinginsertion of said needle, whereupon said push member is displaced duringneedle insertion.
 4. The device of claim 3, wherein said push memberdisplacement causes fluid communication to be achieved between saidneedle and said lumen.
 5. The device of claim 1, wherein said firstlocation of said lumen further comprises a hollow spherical member, influid communication with said second location of said lumen.
 6. Thedevice of claim 1, wherein said clamp manipulator further comprises atleast a second tab mechanically connected to said mechanically drivenmember, wherein the depressing of said second tab causes saidmechanically driven member to be energized, with said first and saidsecond tab arranged to cooperatively energize said mechanically drivenmember.
 7. The device of claim 2, wherein said first tab is mechanicallylinked to said sealing means, wherein said depressing of said first tabfurther causes said sealing means to tightly seal around said needle. 8.The device of claim 6, wherein said clamp manipulator further compriseslocking means capable of alternating between a locked and unlockedstate, wherein said locking means, when in said locked state, preventssaid mechanically driven member from being energized until said lockingmeans has been unlocked.
 9. The device of claim 8, wherein said lockingmeans is arranged to unlock in response to the application of pressureto said locking means, such that said mechanically driven member maythen be energized.
 10. The device of claim 1, wherein said at least afirst tab is palpable from outside the body.
 11. The device of claim 1,wherein said needle receptor is palpable from outside the body.
 12. Thedevice of claim 1, wherein said device further comprises a second needlereceptor, with said receptors being located such that said needle may beintroduced at a plurality of locations.
 13. A subcutaneous vascularaccess device designed for repeated use comprising: a first needlereceptor, wherein said first needle receptor is located on a proximalend of said device and is arranged to accept a needle having a distaltip that is inserted from outside the body, and said first needlereceptor further comprises: a coaxially oriented funnel shaped memberarranged to center the placement of said needle in said first needlereceptor, wherein said funnel shaped member comprises: a graduallydecreasing opening arranged to slidably accept the distal tip of saidneedle, wherein said opening serves to center said needle relative tosaid funnel shaped member; a channel arranged to slidably accept saidneedle following the alignment of said needle with said channel uponcentering in said funnel shaped member, whereupon said needle may beinserted into said channel; a sealing means located in said channel,wherein said sealing means serves to seal any gaps between said needleand said channel; a hollow spherical member arranged to be intersectedby said Funnel shaped member; a lumen, wherein said lumen is arranged tointersect said spherical member at a first location and with said lumenbeing arranged to be anastomosed to a native body lumen at a secondlocation, with said second location also serving as a distal end of saiddevice, thereby causing fluid communication between said funnel shapedmember, said hollow spherical member and said lumen; a lumen clampingmeans comprising: at least two clamping members arranged with an elasticmember which serves to compress said lumen at a location between saidfirst location and said second location, thereby providing a seal alongsaid anastomosis and prohibiting fluid flow therethrough; a mechanicallydriven member arranged to be energized to oppose the restriction of saidelastic member to cause diametrically opposed motion of the said atleast two clamping members thereby decompressing said lumen to providefluid communication between said native body lumen and said firstlocation; and a clamp manipulator comprising at least a first tabarranged to act upon said mechanically driven member, wherein thedepressing of said first tab causes said mechanically driven member tobe energized, thereby providing fluid communication through said lumen.14. The device of claim 13, wherein said funnel shaped member intersectswith said hollow spherical member at a position that is tangential tothe hollow spherical member, thereby promoting laminar flow of fluidwithin said hollow spherical member.
 15. The device of claim 13, whereinsaid clamp manipulator further comprises at least a second tab arrangedto act upon said mechanically driven member.
 16. The device of claim 13,wherein said clamp manipulator further comprises locking means having alocked and an unlocked state, wherein said locking means in said lockedstate secures said at least one tab, and prevents said mechanicallydriven member from being energized until said locking means enters anunlocked state.
 17. The device of claim 16, wherein said locking meansis arranged to unlock following the application of pressure to saidlocking means while in said locked state.
 18. The device of claim 13,wherein said device further comprises at least a second needle receptor,with said receptors being located such that said needle may beintroduced at a plurality of locations.
 19. The device of claim 13,wherein said at least two clamping members are further arranged tocontact said device lumen in an orientation substantially parallel withsaid bodily lumen, wherein said orientation serves to provide a sealwith the native body lumen without creating flow disruptions orstagnations in said native body lumen or in said device lumen.
 20. A kitfor access to bodily lumens enabling a procedure to be completed onfluid removed therefrom prior to the return of such fluid, comprising: afirst device as claimed in claim 1, wherein said first device isarranged to be implanted such that said native bodily lumen consists ofan artery; and a second device as claimed in claim 1, wherein saidsecond device is arranged to be implanted such that said native bodilylumen consists of a vein; wherein said first device serves to enable theremoval of fluid from said artery, and said second device serves toinfuse said fluid into said vein following said procedure.